Clinical trial NCT00964665: Pharmacokinetic/Pharmacodynamic of Albinterferon Alfa-2b in Chronic Hepatitis B, eAg+, Infection Subjects
Official title: A Pharmacokinetic/Pharmacodynamic Evaluation of ABF656 in Subjects With Chronic Hepatitis B, e Ag+, Infection.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Chronic Hepatitis B
Keywords: Hepatitis B,
Chronic,
Hepatitis B e Antigens positive
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Human Genome Sciences Inc.
First posted: 2009-08-25
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy of ABF656 in chronic hepatitis B characterized by HBeAg positivity. The study is designed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase 3 trials. The trial is also designed to generate the PK data in hepatitis B patients to satisfy regulatory requirements in China.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18-75 years of either non-child bearing potential or if of child bearing potential on two adequate forms of birth control
* Chronic HBV infection (serum HBsAg detectable for \> 6 months)
* Serum HBeAg positive with HBV DNA \>106copies/mL (or \>200,000 IU/mL)
* Serum ALT must be \> 2 x ULN but below 10 x ULN

Exclusion Criteria:

* Steroid treatment or immunosuppression 3 months prior to entry.
* Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
* Hb\< 10g/dL or, and ANC \< 750/mm3 or , and platelet count \< 75,000 mm3 .
* Significant chronic medical conditions other than chronic hepatitis B which in the opinion of the investigator preclude enrollment into the study.
* Evidence of hepatic decompensation (i.e., Child-Pugh score of B or C).
* Seropositive for HIV, HCV, or HDV (Hepatitis Delta virus).
* History of hypothyroidism or current treatment for thyroid disease.
* Patients with treated or untreated malignancy of any organs, with the exception of localized basal cell carcinoma

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Evaluate the safety, tolerability and pharmacodynamic effect of various doses of albinterferon alfa-2b in hepatitis B patients on seroconversion of hepatitis markers. Measure: Clinical laboratory. HBV DNA level and HBeAg seroconversion rate.
timeFrame: 48 weeks
Secondary outcomes:
measure: Evaluate the pharmacokinetics at different doses of albinterferon alfa-2b in patients with chronic hepatitis B infection. Measure: Serum concentration of albinterferon alfa-2b
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis Investigator Site
city: Sha Tin
country: Hong Kong
facility: Novartis Investigator Site
city: Taipo
country: Hong Kong
facility: Novartis Investigator Site
city: Bialystok
country: Poland
facility: Novartis Investigator Site
city: Lodz
country: Poland
facility: Novartis Investigator Site
city: Warsaw
country: Poland
facility: Novartis Investigator Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigator Site
city: Taipei
country: Taiwan
facility: Novartis Investigator Site
city: Tau-Yuan County
country: Taiwan
facility: Novartis Investigator Site
city: Bangkok
country: Thailand
facility: Novartis Investigator Site
city: Chiangmai
country: Thailand
facility: Novartis Investigator Site
city: Songkla
country: Thailand
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Institute for BioMedical Research
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Cooksley WG, Piratvisuth T, Lee SD, Mahachai V, Chao YC, Tanwandee T, Chutaputti A, Chang WY, Zahm FE, Pluck N. Peginterferon alpha-2a (40 kDa): an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B. J Viral Hepat. 2003 Jul;10(4):298-305. doi: 10.1046/j.1365-2893.2003.00450.x.
citation: Colvin RA, Tanwandee T, Piratvisuth T, Thongsawat S, Hui AJ, Zhang H, Ren H, Chen PJ, Chuang WL, Sobhonslidsuk A, Li R, Qi Y, Praestgaard J, Han Y, Xu J, Stein DS; ABF656A2206 Study Group. Randomized, controlled pharmacokinetic and pharmacodynamic evaluation of albinterferon in patients with chronic hepatitis B infection. J Gastroenterol Hepatol. 2015 Jan;30(1):184-91. doi: 10.1111/jgh.12671.