Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection
- Conditions
- Chronic Hepatitis C Virus Infection
- Interventions
- Registration Number
- NCT04382937
- Lead Sponsor
- PharmaEssentia
- Brief Summary
Primary objective:
To demonstrate non-inferiority in sustained virologic response (SVR, undetectable HCV RNA at Follow up week 12) between PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily and P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily for the treatment of chronic HCV genotype 2 infection
- Detailed Description
Secondary objective:
To determine and compare the efficacy, safety, tolerability and immunogenicity of PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily and P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 222
- Adults ≥18 years of age (or other age required by local regulations); subjects who are over 70 years of age must be in generally good health.
- Confirmed diagnosis of chronic hepatitis with HCV genotype 2 infection. Chronicity is defined as having proven clinical evidence of chronic hepatitis, e.g. a duration of disease longer than 24 weeks before dosing, OR positive for anti-HCV antibody and HCV RNA at screening with biopsy-proven chronic hepatitis C, OR fibrosis.
- Compensated liver disease defined by normal or elevated ALT ≤10 x ULN, total bilirubin level <2 mg/dL (except in Gilbert's syndrome), normal albumin, normal INR (INR ≤1.5)
- Interferon treatment naïve: never received any interferon.
- No other known form of chronic liver disease apart from chronic hepatitis C infection. But mild and moderate fatty liver diseases can be included.
- Hemoglobin ≥12 g/dL in men or ≥11 g/dL in women, WBC count ≥3,000/mm3, ANC ≥1,500/mm3, platelet count ≥90,000/mm3; and estimated glomerular filtration rate >60 mL/min.
- Female and male subjects, and their partners of reproductive potential using effective means of contraception during the whole trial period.
- Be able to attend all scheduled visits and to comply with all study procedures;
- Be able to provide written informed consent.
Any of the following is cause for exclusion from the study:
- Decompensated liver disease, including overt clinical symptom and sign of complications related to portal hypertension.
- Clinically significant illness or surgery within 4 weeks prior to dosing.
- Any reason which, in the opinion of the investigator, would prevent the subject from participating in the study.
- Positive test for hepatitis B surface antigen or human immunodeficiency virus at screening.
- Clinically significant abnormal vital signs at screening.
- Evidence of severe retinopathy by fundoscopy except age-related macular degeneration at screening.
- Significant alcohol or illicit drug abuse within one year prior to the screening visit or refusal to abstain from excessive alcohol consumption as defined above or illicit drugs throughout the study.
- Pregnant or breast feeding female subjects.
- Therapy with any systemic anti-viral, anti-neoplastic, and immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) within 4 weeks prior to the first dose of study drug.
- Use of an investigational drug or participation in an investigational drug trial within 4 weeks from the first dose.
- Known clinically significant presence of any gastrointestinal pathology, clinically significant unresolved gastrointestinal symptoms, clinically significant liver (other than CHC) or clinically significant kidney disease (including but not limited to those with chronic renal failure on dialysis), or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
- Hospital Anxiety and Depression Scale (HADS) score >10 on depression scale at screening that indicates clinically significant presence of depression determined by investigators.
- Clinically significant presence of severe neurological disorders, e.g. uncontrolled seizure disorders.
- Clinically significant presence of severe cardiovascular conditions and severe pulmonary conditions (including but not limited to pulmonary infiltrates, pneumonia, pneumonitis, chronic obstructive lung disease), uncontrolled immunologic, uncontrolled autoimmune, uncontrolled endocrine, uncontrolled metabolic, haematological, severe coagulation disorders or severe blood dyscrasias or other severe uncontrolled systemic disease.
- A depot injection or an implant of any drug within 3 months prior to administration of study medication, other than contraception or hyaluronic acid injections in joints for osteoarthritis;
- Body organ transplant and are taking immunosuppressants;
- History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured, and carcinoma in situ of cervix); However, subjects who are cancer survivors not on maintenance therapy and who had no malignant diseases history within the past 5 years could be recruited.
- History of or ongoing opportunistic infection.
- Serious local infection or systemic infection within the 3 months prior to screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PEG-Intron + Ribavirin PEG-Intron + Ribavirin PEG-Intron 1.5 µg per kg SC Q1W P1101 + Ribavirin P1101 + Ribavirin P1101 400 µg SC Q2W
- Primary Outcome Measures
Name Time Method Subjects with undetectable serum HCV RNA at follow up week 12 Follow Week 12 Percentage of subjects with SVR12 (undetectable serum HCV RNA, i.e. \<12 IU/mL, at follow up week 12) in each treatment group
- Secondary Outcome Measures
Name Time Method Number of subjects with clinically significant laboratory abnormalities Through study Follow Week 24 Number of subjects with clinically significant laboratory abnormalities in each treatment group
Subjects with undetectable serum HCV RNA Treatment Week 4, 8, 12, 24 and Follow Week 24 Percentage of subjects with undetectable serum HCV RNA at treatment week 4, 8, 12, 24 (end of treatment) and follow up week 24 in each treatment group
Number of subjects with adverse events Through study Follow Week 24 Number of subjects with adverse events in each treatment group
Subjects with anti-drug antibodies Follow Week 12 and 24 Percentage of subjects with positive anti-drug antibodies (the anti-peginterferon and the anti-Peg) at follow up week 12 and 24
Subjects with neutralizing antibody Follow Week 12 and 24 Percentage of subjects with positive neutralizing antibody at follow up week 12 and 24
Trial Locations
- Locations (39)
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, China
Inha University Medical Center
🇰🇷Incheon, Korea, Republic of
The First Hospital of Lanzhou University
🇨🇳Gansu, China
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Saint Vincent Catholic Hospital
🇰🇷Suwon, Korea, Republic of
Soonchunhyang University Seoul Hospital
🇰🇷Asan, Korea, Republic of
Yonsei University Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Gansu Wuwei Tumour Hospital
🇨🇳Gansu, China
Beijing Ditan Hospital Capital Medical University
🇨🇳Beijing, China
Henan Provincial People's Hospital
🇨🇳Henan, China
Luoyang Central Hospital
🇨🇳Henan, China
The First Hospital of Jilin University
🇨🇳Jilin, China
Peace Hospital Affiliated to Changzhi Medical College
🇨🇳Shanxi, China
The Sixth People's Hospital of Shenyang
🇨🇳Shenyang, China
Tangdu Hospital, Fourth Military Medical University
🇨🇳Xi'an, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, China
Xijing Hospital, Fourth Military Medical University
🇨🇳Xi'an, China
Seoul Metropolitan Government - Seoul National University Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Chang Gung Memorial Hospital, Chiayi Branch
🇨🇳Chiayi City, Taiwan
Chang Gung Memorial Hospital, Kaohsiung Branch
🇨🇳Kaohsiung City, Taiwan
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan City, Taiwan
E-Da Hospital
🇨🇳Kaohsiung City, Taiwan
Changhua Christian Hospital
🇨🇳Changhua City, Taiwan
Hualien Tzu Chi Hospital
🇨🇳Hualien City, Taiwan
Chang Gung Memorial Hospital, Keelung Branch
🇨🇳Keelung, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
St. Martin De Porres Hospital
🇨🇳Chiayi City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung City, Taiwan
Chang Gung Memorial Hospital, Linkou
🇨🇳New Taipei City, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung City, Taiwan
Chi Mei Medical Center
🇨🇳Tainan City, Taiwan
National Taiwan University Hospital Yun-Lin Branch
🇨🇳Yuanlin, Taiwan
Chi Mei Hospital, Liouying
🇨🇳Tainan City, Taiwan
Chia-Yi Christian Hospital
🇨🇳Chiayi City, Taiwan
Dalin Tzu Chi Hospital
🇨🇳Chiayi City, Taiwan
Taitung MacKay Memorial Hospital
🇨🇳Taitung, Taiwan
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of