Clinical trial NCT05230550: Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®
Official title: Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya® A Multi-centre, Prospective, Open Label, Single-arm, Observational, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Sogroya® Therapy in Patients With Adult Growth Hormone Deficiency (AGHD) (Only Severe Case) Under Normal Clinical Practice Conditions in Japan
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Adult Growth Hormone Deficiency
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-02-09
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Adult Growth Hormone Deficiency (only severe case)

Brief summary: Participants are invited to take part in this study because they have AGHD (only severe case). The purpose of this study is to assess long term safety and effectiveness of Sogroya® in patients with AGHD (only severe case) under normal clinical practice condition in Japan. Participants will get Sogroya® as prescribed by the study doctor. Participants will be in the study for about 2 to 5 years depending on when they take part in the study. Participants will be asked to fill in the quality of life questionnaires.


Eligibility criteria: Inclusion Criteria:

1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
2. The decision to initiate treatment with commercially available Sogroya® has been made by the patient/LAR and the treating physician before and independently from the decision to include the patient in this study.
3. Male or female, no age limitation
4. Diagnosis of AGHD (only severe case)
5. GH treatment naïve ("naïve patients") or "switched patients". "Naïve patients" are patients who are not exposed to any GH product to date or patients who were exposed to other GH product more than 180 days prior to registration. "Switched patients" are patients who is now treated by other GH product or patients who were exposed to other GH product within 180 days prior to registration.

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
3. Patients with hypersensitivity to the active substance or to any of the excipients
4. Patients with malignant tumor
5. Female patients who are either pregnant or likely to be pregnant

Primary outcomes:
measure: Number of adverse events
timeFrame: From baseline (week 0) to end of study (up to 260 weeks)
measure: Number of serious adverse events
timeFrame: From baseline (week 0) to end of study (up to 260 weeks)
measure: Number of serious adverse reactions
timeFrame: From baseline (week 0) to end of study (up to 260 weeks)
measure: Number of adverse reactions
timeFrame: From baseline (week 0) to end of study (up to 260 weeks)
Secondary outcomes:
measure: Change in body fat mass
timeFrame: From baseline (week 0) to end of study (up to 260 weeks)
measure: Change in body fat percentage
timeFrame: From baseline (week 0) to end of study (up to 260 weeks)
measure: Change in lean body mass
timeFrame: From baseline (week 0) to end of study (up to 260 weeks)
measure: Change in cross-sectional total adipose tissue compartments (TAT)
timeFrame: From baseline (week 0) to end of study (up to 260 weeks)
measure: Change in subcutaneous adipose tissue compartments (SAT)
timeFrame: From baseline (week 0) to end of study (up to 260 weeks)
measure: Change in visceral adipose tissue compartments (VAT)
timeFrame: From baseline (week 0) to end of study (up to 260 weeks)
measure: Change in Total cholesterol (T-Cho)
timeFrame: From baseline (week 0) to end of study (up to 260 weeks)
measure: Change in Low Density Lipoprotein-Cholesterol (LDL-Cho)
timeFrame: From baseline (week 0) to end of study (up to 260 weeks)
measure: Change in High Density Lipoprotein-Cholesterol (HDL-Cho)
timeFrame: From baseline (week 0) to end of study (up to 260 weeks)
measure: Change in triglyceride
timeFrame: From baseline (week 0) to end of study (up to 260 weeks)
measure: Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS)
timeFrame: From baseline (week 0) to end of study (up to 260 weeks)
measure: Change in Quality of Life (QOL) Adult Hypopituitarism Questionnaire (AHQ) score
timeFrame: From baseline (week 0) to end of study (up to 260 weeks)
measure: Change in QOL Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD) score
timeFrame: From baseline (week 0) to end of study (up to 260 weeks)
Other outcomes:
Locations:
city: Amagasaki-shi, Hyogo
country: Japan
facility: Ikeda Hospital, Diabetes Medicine
city: Chuo-shi, Yamanashi-ken
country: Japan
facility: University of Yamanashi Hospital
city: Fukuoka-shi, Fukuoka-ken
country: Japan
facility: Fukuoka University Hospital
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukuoka
country: Japan
facility: Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus
city: Fukuoka
country: Japan
facility: Kurume University Hospital
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Goshogawara-shi, Aomori-ken
country: Japan
facility: Tsugaru General Hospital
city: Gunma
country: Japan
facility: Gunma University Hospital, Dept. of Endocrinology and Diabetes
city: Hamamatsu-shi, Shizuoka
country: Japan
facility: Hamamatsu University Hospital
city: Hirosaki-shi, Aomori-ken
country: Japan
facility: Hirosaki University Hospital
city: Hyogo
country: Japan
facility: Hyogo Prefectural Kakogawa Medical Center
city: Iida-shi, Nagano-ken
country: Japan
facility: Takara Clinic
city: Izumo, Shimane
country: Japan
facility: Shimane Univ. HP, Dept of Endocrinology&Metabolism
city: Joetsu-shi, Niigata-ken
country: Japan
facility: Joetsu General Hospital
city: Kagoshima-shi, Kagoshima-ken
country: Japan
facility: Kagoshima Medical Center
city: Kagoshima-shi, Kagoshima
country: Japan
facility: Kagoshima University Hospital_Neurosurgery
city: Kanagawa
country: Japan
facility: Yokohama Medical Center
city: Kanagawa
country: Japan
facility: Kitasato University Hospital
city: Kashihara-shi, Nara
country: Japan
facility: Nara Medical University Hospital_Kashihara-shi, Nara
city: Kawasaki-shi, Kanagawa
country: Japan
facility: Nippon Medical School Musashikosugi Hospital_Neurological Surgery
city: Kobe-shi, Hyogo
country: Japan
facility: Kobe University Hospital
city: Kumamoto-shi, Kumamoto
country: Japan
facility: Kumamoto University Hospital, Diabetes, Metabo and Endo
city: Kumamoto
country: Japan
facility: Konan Hospital
city: Kyoto-shi, Kyoto
country: Japan
facility: Kyoto University Hospital
city: Minato-ku, Tokyo
country: Japan
facility: Toranomon Hospital, Endocrinology and Metabolism
city: Miyazaki-shi, Miyazaki-ken
country: Japan
facility: University of Miyazaki Hospital
city: Nagakute-shi, Aichi
country: Japan
facility: Aichi Medical University Hospital
city: Nara
country: Japan
facility: Okamoto Internal Medicine and Pediatrics Clinic
city: Nishinomiya-shi, Hyogo-ken
country: Japan
facility: Kurebayashi Diabetes Clinic
city: Okayama-shi, Okayama
country: Japan
facility: Okayama University Hospital_General Medicine
city: Oosakashi
country: Japan
facility: Kibounomori Clinic
city: Osaka
country: Japan
facility: Osaka Endocrine Clinic
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Osaka
country: Japan
facility: Yasuhara Children's Clinic
city: Osaka
country: Japan
facility: Osaka Women's and Children's Hospital
city: Sapporo, Hokkaido
country: Japan
facility: NTT East Japan Sapporo HP, Diabetes Mellitus & Int med Endo
city: Sendai-shi, Miyagi-ken
country: Japan
facility: JCHO Sendai Hospital
city: Shiga
country: Japan
facility: Omi Medical Center
city: Shizuoka-shi, Shizuoka-ken
country: Japan
facility: Shizuoka General Hospital
city: Shizuoka
country: Japan
facility: Hamamatsu-kita-Hospital
city: Shizuoka
country: Japan
facility: Hamamatsu Medical Center
city: Tochigi-shi, Tochigi-ken
country: Japan
facility: Tochigi Medical Center Shimotsuga
city: Tokyo
country: Japan
facility: Hosaka Kodomo Clinic
city: Toon-shi, Ehime
country: Japan
facility: Ehime University Hospital
city: Tottori
country: Japan
facility: Tottori University Hospital_Endocrinology and Metabolism
city: Yamagata-shi, Yamagata
country: Japan
facility: Yamagata University Hospital, Internal Medicine 3
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References: