Clinical trial NCT04687072: A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
Official title: A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Immune Thrombocytopenia
Lead sponsor: argenx
Sponsor class: INDUSTRY
First posted: 2020-12-29
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, and effect on QoL/PRO of efgartigimod PH20 SC treatment in adult patients with primary ITP.


Eligibility criteria: Inclusion criteria:

* Ability to understand the requirements of the trial and provide written informed consent, willing and able to comply with the trial protocol procedures
* Is at least the local age of consent for clinical studies when signing the ICF.
* Confirmed diagnosis of primary ITP made at least 3 months before randomization and based on the American Society of Hematology Criteria, and no known etiology for thrombocytopenia
* Diagnosis supported by a response to a prior ITP therapy (other than TPO-RAs), in the opinion of the investigator
* Mean platelet count of \<30×10E9/L from at least 3 documented, qualifying counts within the 3 preceding months where at least 2 of the qualifying counts must be taken during the screening period: 1 platelet count collected during the screening period and the predose platelet count on the day of randomization (visit 1). If the third count is not available from the 3 preceding months, this third platelet count can be obtained during the screening period.
* A documented history of a platelet count of \<30×10E9/L before screening
* At the start of the trial, the participant either takes concurrent ITP treatment(s) and has received at least 1 prior therapy for ITP in the past, or the participant does not take treatment for ITP (see note) but has received at least 2 prior treatments for ITP. Participants receiving permitted concurrent ITP treatment(s) at baseline must have been stable in dose and frequency for at least 4 weeks before randomization.

Permitted concurrent ITP medications include corticosteroids, danazol, vinca alkaloids, oral immunosuppressants, dapsone, fostamatinib, and/or oral TPO-RAs.

-Agree to use contraceptive measures consistent with local regulations and the protocol

Exclusion criteria:

* Secondary ITP/thrombocytopenia associated with another condition, eg, lymphoma, chronic lymphocytic leukemia, viral infection, hepatitis, induced or alloimmune thrombocytopenia, thrombocytopenia associated with myeloid dysplasia, or hematopoietic stem cell transplant
* Use of anticoagulants (eg, vitamin K antagonists, direct oral anticoagulants) within 4 weeks prior to randomization
* Use of any transfusions within 4 weeks prior to randomization
* Use of Ig (IV, SC, or intramuscular route) or plasmapheresis (PLEX) within 4 weeks prior to randomization
* Use of romiplostim within 4 weeks prior to randomization
* Undergone splenectomy less than 4 weeks prior to randomization
* Use of an investigational product within 3 months or 5 half-lives (whichever is longer) before the first dose of the IMP
* Use of any monoclonal antibody or Fc fusion proteins, other than those previously indicated, within 6 months before the first dose of the IMP (eg, anti-CD20)
* At the screening visit, clinically significant laboratory abnormalities as follows: Hemoglobin ≤9 g/dL - OR - International normalized ratio \>1.5 or activated partial thromboplastin time \>1.5×upper limit of normal - OR - total IgG level \<6 g/L
* History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of IMP. Participants with the following cancer can be included at any time: Adequately treated basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast or Incidental histological finding of prostate cancer (TNM stage T1a or T1b)
* Uncontrolled hypertension, defined as a repeated elevated blood pressure exceeding 160 mmHg (systolic) and/or 100 mmHg (diastolic) despite appropriate treatments
* History of any major thrombotic or embolic event (eg, myocardial infarction, stroke, deep venous thrombosis, or pulmonary embolism) within 5 years prior to randomization
* History of coagulopathy or hereditary thrombocytopenia or a family history of thrombocytopenia
* Evidence of an active clinically significant bleeding of an organ or internal mucosal bleeding, other than expected in ITP, that warrants emergent treatment or therapeutic procedure based on the investigator's judgment (eg, intracranial hemorrhage, pulmonary hemorrhage, bleeding with ongoing need for packed red blood cell transfusion)
* Estimated high risk of a clinically significant bleeding of an organ or internal mucosal bleeding, other than expected in ITP, that warrants emergent treatment or therapeutic procedure according to the investigator's judgment
* Clinical evidence of other significant serious diseases, have had a recent major surgery, or who have any other condition in the opinion of the investigator, that could confound the results of the trial or put the participant at undue risk
* Positive serum test at screening for an active viral infection with any of the following conditions: Hepatitis B virus (HBV) that is indicative of an acute or chronic infection, unless associated with a negative HBV DNA test, Hepatitis C virus (HCV) based on HCV-antibody assay (unless associated with a negative HCV RNA test), Human immunodeficiency virus (HIV) based on test results that are associated with an acquired immunodeficiency syndrome (AIDS)-defining condition or a CD4 count ≤200 cells/mm3
* Known hypersensitivity reaction to efgartigimod, rHuPH20, or 1 of its excipients
* Previously participated in a clinical trial with efgartigimod and have received at least 1 administration of the IMP
* Pregnant or lactating or intends to become pregnant during the trial
* Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at screening
* Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of ITP or put the participant at undue risk
* Clinical evidence of significant unstable or uncontrolled acute or chronic diseases other than ITP (eg, cardiovascular, pulmonary, hematologic, gastrointestinal, endocrine, hepatic, renal, neurological, malignancy, infectious diseases, uncontrolled diabetes) despite appropriate treatments which could put the participant at undue risk
* Current or history of (ie, within 12 months of screening) alcohol, drug, or medication abuse
* Received a live/live-attenuated vaccine less than 4 weeks before screening. The receipt of any inactivated, sub-unit, polysaccharide, or conjugate vaccine at any time before screening is not considered an exclusion criterion

Primary outcomes:
measure: Percentage of Participants With Chronic Immune Thrombocytopenia (ITP) With a Sustained Platelet Count Response Between Weeks 19 and 24
timeFrame: Up to 6 weeks (between Weeks 19 and 24)
Secondary outcomes:
measure: Extent of Disease Control Over the 24-Week Treatment Period in the Chronic ITP Population
timeFrame: Up to 24 weeks
measure: Percentage of Participants in the Overall Population (Chronic and Persistent ITP) With a Sustained Platelet Count Response Between Weeks 19 and 24
timeFrame: Up to 6 weeks (between Weeks 19 and 24)
measure: Percentage of Participants in the Overall Population With Sustained Platelet Count Response Between Weeks 17 and 24
timeFrame: Up to 8 weeks (between Weeks 17 and 24)
measure: Percentage of Participants in the Overall Population Achieving Overall Platelet Count Response at Any Time During the 24-week Treatment Period
timeFrame: Up to 24 weeks
measure: Extent of Disease Control Until Week 12 in the Overall Population
timeFrame: Up to 12 weeks
measure: Percentage of Participants in the Overall Population Achieving Overall Platelet Count Response at Any Time Until Week 12
timeFrame: Up to 12 weeks
measure: Mean Change From Baseline in Platelet Count at Each Visit in the Overall Population
timeFrame: Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, Safety and Efficacy Follow-up Visit 1 (SEFU1) (up to Week 29), and SEFU2 (up to Week 33)
measure: Time to Platelet Count Response in the Overall Population
timeFrame: Up to 24 weeks
measure: Extent of Disease Control Over the 24-Week Treatment Period in the Overall Population
timeFrame: Up to 24 weeks
measure: Extent of Disease Control Over the 24-Week Treatment Period in the Overall Population for Participants With Baseline Platelet Count of <15×10^9/L
timeFrame: Up to 24 weeks
measure: Number of the World Health Organization (WHO)-Classified Bleeding Events (Grade ≥1) in the Overall Population
timeFrame: Up to 24 weeks
measure: Percentage of Participants With a Platelet Count International Working Group (IWG) Response
timeFrame: Up to 24 weeks
measure: Rate of Receipt of Rescue Therapy (Rescue Per Participant Per Month) in the Overall Population
timeFrame: Up to 24 weeks
measure: Percentage of Participants for Whom Dose and/or Frequency of Concurrent ITP Therapies Have Increased at Week 12 or Later in the Overall Population
timeFrame: Up to 13 weeks (between Weeks 12 and 24)
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue) at Week 24 in the Overall Population
timeFrame: Baseline and Week 24
measure: Change From Baseline in Functional Assessment of Cancer Therapy Questionnaire-Th6 (Fact-Th6) at Week 24 in the Overall Population
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, and 24
measure: Change From Baseline in Short Form-36 (SF-36) at Week 24 in the Overall Population
timeFrame: Baseline and Week 24
measure: Incidence and Prevalence of Antibodies to Efgartigimod and/or rHuPH20 in the Overall Population
timeFrame: Up to 35 weeks
measure: Titers of Antibodies to Efgartigimod and/or rHuPH20 in the Overall Population
timeFrame: Weeks 3, 7, 11, 15, 19, 23, 24, SEFU1 (up to Week 29), and SEFU2 (up to Week 33)
measure: Incidence and Prevalence of Neutralizing Antibodies (NAb) to Efgartigimod and/or rHuPH20 in the Overall Population
timeFrame: Up to 35 weeks
measure: Serum Efgartigimod Trough Concentration (Ctrough) in the Overall Population
timeFrame: Predose on Weeks 1, 2, 3, 17, 19, 21, 23, and 24
measure: Percentage Change From Baseline in Total IgG in the Overall Population
timeFrame: Baseline and Weeks 1, 2, 3, 17, 19, 21, 23, and 24
measure: Number of Participants With Antiplatelet Antibodies in the Overall Population
timeFrame: Weeks 7, 15, 23, and 24
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Investigator Site 0010116
state: Arkansas
city: Los Angeles
country: United States
facility: Investigator site 0010036
state: California
city: Washington
country: United States
facility: Investigator Site 0010045
state: District of Columbia
city: Weston
country: United States
facility: Investigator Site 0010104
state: Florida
city: Chicago
country: United States
facility: Investigator site 0010112
state: Illinois
city: Chicago
country: United States
facility: Investigator site 0010193
state: Illinois
city: Lisle
country: United States
facility: Investigator Site 0010079
state: Illinois
city: Fort Wayne
country: United States
facility: Investigator Site 0010062
state: Indiana
city: Iowa City
country: United States
facility: Investigator site 0010042
state: Iowa
city: Detroit
country: United States
facility: Investigator Site 0010083
state: Michigan
city: Minneapolis
country: United States
facility: Investigator Site 0010102
state: Minnesota
city: Columbus
country: United States
facility: Investigator site 0010040
state: Ohio
city: Oklahoma City
country: United States
facility: Investigator Site 0010095
state: Oklahoma
city: Pittsburgh
country: United States
facility: Investigator Site 0010115
state: Pennsylvania
city: Buenos Aires
country: Argentina
facility: Investigator Site 0540001
city: Buenos Aires
country: Argentina
facility: Investigator Site 0540004
city: Córdoba
country: Argentina
facility: Investigator Site 0540003
city: Adelaide
country: Australia
facility: Investigator Site 0610009
city: Bedford Park
country: Australia
facility: Investigator Site 0610004
city: Box Hill
country: Australia
facility: Investigator Site 0610002
city: Clayton
country: Australia
facility: Investigator Site 0610010
city: Garran
country: Australia
facility: Investigator Site 0610012
city: Hobart
country: Australia
facility: Investigator Site 0610001
city: Perth
country: Australia
facility: Investigator Site 0610011
city: West Perth
country: Australia
facility: Investigator Site 0610003
city: Westmead
country: Australia
facility: Investigator Site 0610005
city: Plovdiv
country: Bulgaria
facility: Investigator Site 3590017
city: Sofia
country: Bulgaria
facility: Investigator Site 3590015
city: Santiago
country: Chile
facility: Investigator Site 0560002
city: Temuco
country: Chile
facility: Investigator Site 0560004
city: Viña Del Mar
country: Chile
facility: Investigator Site 0560003
city: Beijing
country: China
facility: Investigator Site 0860003
city: Beijing
country: China
facility: Investigator Site 0860013
city: Bengbu
country: China
facility: Investigator Site 0860008
city: Huizhou
country: China
facility: Investigator Site 0860055
city: Kunming
country: China
facility: Investigator Site 0860009
city: Nanchang
country: China
facility: Investigator Site 0860012
city: Shanxi
country: China
facility: Investigator Site 0860014
city: Shenzhen
country: China
facility: Investigator Site 0860015
city: Tianjin
country: China
facility: Investigator Site 0860001
city: Wenzhou
country: China
facility: Investigator Site 0860006
city: Wuhan
country: China
facility: Investigator Site 0860010
city: Wuxi
country: China
facility: Investigator Site 0860002
city: Zhejiang
country: China
facility: Investigator Site 0860005
city: Zhengzhou
country: China
facility: Investigator Site 0860011
city: Zhenjiang
country: China
facility: Investigator Site 0860058
city: Zhenjiang
country: China
facility: Investigator site 0860062
city: Roskilde
country: Denmark
facility: Investigator Site 0450005
city: Créteil
country: France
facility: Investigator Site 0330009
city: Montpellier
country: France
facility: Investigator Site 0330018
city: Tbilisi
country: Georgia
facility: Investigator Site 9950006
city: Tbilisi
country: Georgia
facility: Investigator Site 9950007
city: Tbilisi
country: Georgia
facility: Investigator Site 9950008
city: Tbilisi
country: Georgia
facility: Investigator Site 9950009
city: Tbilisi
country: Georgia
facility: Investigator Site 9950011
city: Tbilisi
country: Georgia
facility: Investigator Site 9950019
city: Essen
country: Germany
facility: Investigator site 0490008
city: Gießen
country: Germany
facility: Investigator Site 0490012
city: Athens
country: Greece
facility: Investigator Site 0300008
city: Athens
country: Greece
facility: Investigator Site 0300010
city: Patra
country: Greece
facility: Investigator Site 0300007
city: Thessaloníki
country: Greece
facility: Investigator Site 0300009
city: Dublin
country: Ireland
facility: Investigator Site 3530002
city: Dublin
country: Ireland
facility: Investigator Site 3530003
city: Galway
country: Ireland
facility: Investigator Site 3530001
city: Ashkelon
country: Israel
facility: Investigator Site 9720013
city: Haifa
country: Israel
facility: Investigator Site 9720010
city: Haifa
country: Israel
facility: Investigator Site 9720012
city: Jerusalem
country: Israel
facility: Investigator Site 9720008
city: Jerusalem
country: Israel
facility: Investigator Site 9720011
city: Petach Tikva
country: Israel
facility: Investigator Site 9720007
city: Tel Aviv
country: Israel
facility: Investigator Site 9720009
city: Alessandria
country: Italy
facility: Investigator Site 0390037
city: Ferrara
country: Italy
facility: Investigator Site 0390043
city: Meldola
country: Italy
facility: Investigator Site 0390045
city: Milan
country: Italy
facility: Investigator site 0390014
city: Milan
country: Italy
facility: Investigator Site 0390032
city: Napoli
country: Italy
facility: Investigator Site 0390041
city: Napoli
country: Italy
facility: Investigator Site 0390044
city: Novara
country: Italy
facility: Investigator Site 0390015
city: Potenza
country: Italy
facility: Investigator Site 0390035
city: Reggio Calabria
country: Italy
facility: Investigator Site 0390011
city: Reggio Emilia
country: Italy
facility: Investigator site 0390018
city: Rome
country: Italy
facility: Investigator Site 0390046
city: Terni
country: Italy
facility: Investigator Site 0390033
city: Varese
country: Italy
facility: Investigator Site 0390036
city: Chiba
country: Japan
facility: Investigator Site 0810056
city: Hirakata
country: Japan
facility: Investigator Site 0810015
city: Hiroshima
country: Japan
facility: Investigator Site 0810010
city: Kanagawa
country: Japan
facility: Investigator Site 0810053
city: Kitakyushu
country: Japan
facility: Investigator Site 0810051
city: Kumamoto
country: Japan
facility: Investigator Site 0810054
city: Maebashi
country: Japan
facility: Investigator Site 0810018
city: Morioka
country: Japan
facility: Investigator Site 0810057
city: Saitama
country: Japan
facility: Investigator Site 0810017
city: Shibukawa
country: Japan
facility: Investigator Site 0810016
city: Shimotsuke
country: Japan
facility: Investigator Site 0810023
city: Shinagawa-Ku
country: Japan
facility: Investigator Site 0810039
city: Tama
country: Japan
facility: Investigator Site 0810038
city: Tokyo
country: Japan
facility: Investigator Site 0810052
city: Tsukuba
country: Japan
facility: Investigator Site 0810048
city: Yamanashi
country: Japan
facility: Investigator Site 0810044
city: Ōgaki
country: Japan
facility: Investigator Site 0810012
city: Amman
country: Jordan
facility: Investigator Site 9620002
city: Irbid
country: Jordan
facility: Investigator Site 9620001
city: Seongnam
country: Korea, Republic of
facility: Investigator Site 0820005
city: Seoul
country: Korea, Republic of
facility: Investigator Site 0820003
city: Seoul
country: Korea, Republic of
facility: Investigator Site 0820004
city: Seoul
country: Korea, Republic of
facility: Investigator Site 0820006
city: Seoul
country: Korea, Republic of
facility: Investigator Site 0820007
city: Seoul
country: Korea, Republic of
facility: Investigator Site 0820008
city: Aguascalientes
country: Mexico
facility: Investigator Site 0520002
city: Chihuahua
country: Mexico
facility: Investigator Site 0520004
city: Mexico
country: Mexico
facility: Investigator Site 0520007
city: Monterrey
country: Mexico
facility: Investigator Site 0520003
city: Oaxaca
country: Mexico
facility: Investigator Site 0520001
city: Auckland
country: New Zealand
facility: Investigator Site 0640001
city: Christchurch
country: New Zealand
facility: Investigator Site 0640005
city: Palmerston North
country: New Zealand
facility: Investigator Site 0640002
city: Bergen
country: Norway
facility: Investigator Site 0470002
city: Oslo
country: Norway
facility: Investigator Site 0470003
city: Katowice
country: Poland
facility: Investigator Site 0480013
city: Lublin
country: Poland
facility: Investigator Site 0480014
city: Nowy Sącz
country: Poland
facility: Investigator Site 0480026
city: Skorzewo
country: Poland
facility: Investigator Site 0480037
city: Toruń
country: Poland
facility: Investigator Site 0480039
city: Warszawa
country: Poland
facility: Investigator Site 0480033
city: Braga
country: Portugal
facility: Investigator Site 3510006
city: Coimbra
country: Portugal
facility: Investigator Site 3510003
city: Lisboa
country: Portugal
facility: Investigator Site 3510002
city: Lisboa
country: Portugal
facility: Investigator Site 3510005
city: Lisboa
country: Portugal
facility: Investigator Site 3510007
city: Porto
country: Portugal
facility: Investigator Site 3510001
city: Porto
country: Portugal
facility: Investigator Site 3510004
city: Bucharest
country: Romania
facility: Investigator Site 0400005
city: Bucuresti
country: Romania
facility: Investigator Site 0400006
city: Bucuresti
country: Romania
facility: Investigator Site 0400009
city: Bucuresti
country: Romania
facility: Investigator Site 0400012
city: Cluj-Napoca
country: Romania
facility: Investigator Site 0400016
city: Craiova
country: Romania
facility: Investigator Site 0400007
city: Sibiu
country: Romania
facility: Investigator Site 0400011
city: Târgu-Mureş
country: Romania
facility: Investigator Site 0400008
city: Kaluga
country: Russian Federation
facility: Investigator Site 0070006
city: Kirov
country: Russian Federation
facility: Investigator Site 0070040
city: Moscow
country: Russian Federation
facility: Investigator Site 0070026
city: Nizhny Novgorod
country: Russian Federation
facility: Investigator Site 0070038
city: Novosibirsk
country: Russian Federation
facility: Investigator Site 0070037
city: Pyatigorsk
country: Russian Federation
facility: Investigator Site 0070024
city: Saint Petersburg
country: Russian Federation
facility: Investigator Site 0070025
city: Smolensk
country: Russian Federation
facility: Investigator Site 0070039
city: Syktyvkar
country: Russian Federation
facility: Investigator Site 0070015
city: Tula
country: Russian Federation
facility: Investigator Site 0070012
city: Belgrade
country: Serbia
facility: Investigator Site 3810006
city: Kragujevac
country: Serbia
facility: Investigator Site 3810008
city: George
country: South Africa
facility: Investigator Site 0270005
city: Johannesburg
country: South Africa
facility: Investigator Site 0270003
city: Observatory
country: South Africa
facility: Investigator Site 0270004
city: Pretoria
country: South Africa
facility: Investigator Site 0270001
city: Randburg
country: South Africa
facility: Investigator Site 0270002
city: Alava
country: Spain
facility: Investigator Site 0340024
city: Barcelona
country: Spain
facility: Investigator Site 0340007
city: Barcelona
country: Spain
facility: Investigator Site 0340006
city: Barcelona
country: Spain
facility: Investigator Site 0340023
city: Madrid
country: Spain
facility: Investigator Site 0340037
city: Murcia
country: Spain
facility: Investigator Site 0340022
city: Sabadell
country: Spain
facility: Investigator Site 0340036
city: Sevilla
country: Spain
facility: Investigator site 0340013
city: Valencia
country: Spain
facility: Investigator Site 0340004
city: New Taipei City
country: Taiwan
facility: Investigator Site 8860001
city: Taoyuan
country: Taiwan
facility: Investigator Site 8860003
city: Bangkok Noi
country: Thailand
facility: Investigator Site 0660001
city: Bangkok
country: Thailand
facility: Investigator Site 0660002
city: Bangkok
country: Thailand
facility: Investigator Site 0660003
city: Bangkok
country: Thailand
facility: Investigator Site 0660005
city: Bangkok
country: Thailand
facility: Investigator Site 0660008
city: Chiang Mai
country: Thailand
facility: Investigator Site 0660004
city: Khon Kaen
country: Thailand
facility: Investigator Site 0660009
city: Pathum Thani
country: Thailand
facility: Investigator Site 0660006
city: Sfax
country: Tunisia
facility: Investigator Site 2160006
city: Sousse
country: Tunisia
facility: Investigator Site 2160001
city: Tunis
country: Tunisia
facility: Investigator Site 2160002
city: Adapazarı
country: Turkey
facility: Investigator Site 0900007
city: Ankara
country: Turkey
facility: Investigator Site 0900003
city: Ankara
country: Turkey
facility: Investigator Site 0900006
city: Ankara
country: Turkey
facility: Investigator Site 0900008
city: Ankara
country: Turkey
facility: Investigator Site 0900015
city: Edirne
country: Turkey
facility: Investigator Site 0900016
city: Istanbul
country: Turkey
facility: Investigator Site 0900013
city: İzmir
country: Turkey
facility: Investigator Site 0900004
city: Kocaeli
country: Turkey
facility: Investigator Site 0900014
city: Malatya
country: Turkey
facility: Investigator Site 0900018
city: Mersin
country: Turkey
facility: Investigator Site 0900010
city: Samsun
country: Turkey
facility: Investigator Site 0900009
city: Tekirdağ
country: Turkey
facility: Investigator Site 0900017
city: Trabzon
country: Turkey
facility: Investigator Site 0900019
city: Bradford
country: United Kingdom
facility: Investigator site 0440011
city: Coventry
country: United Kingdom
facility: Investigator Site 0440005
city: London
country: United Kingdom
facility: Investigator Site 0440008
city: London
country: United Kingdom
facility: Investigator Site 0440041
city: Truro
country: United Kingdom
facility: Investigator Site 0440014
Study officials:
References: