Clinical trial NCT04382937: Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection
Official title: An Open-label, Randomized, Active Control Study to Demonstrate Non-Inferiority in Efficacy, and to Compare Safety and Tolerability of P1101 + Ribavirin to PEG-Intron + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic HCV Genotype 2 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C Virus Infection
Keywords: P1101
HCV
PEG-Intron
Lead sponsor: PharmaEssentia
Sponsor class: INDUSTRY
First posted: 2020-05-11
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. 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)
4. Interferon treatment naïve: never received any interferon.
5. No other known form of chronic liver disease apart from chronic hepatitis C infection. But mild and moderate fatty liver diseases can be included.
6. 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.
7. Female and male subjects, and their partners of reproductive potential using effective means of contraception during the whole trial period.
8. Be able to attend all scheduled visits and to comply with all study procedures;
9. Be able to provide written informed consent.

Exclusion Criteria:

Any of the following is cause for exclusion from the study:

1. Decompensated liver disease, including overt clinical symptom and sign of complications related to portal hypertension.
2. Clinically significant illness or surgery within 4 weeks prior to dosing.
3. Any reason which, in the opinion of the investigator, would prevent the subject from participating in the study.
4. Positive test for hepatitis B surface antigen or human immunodeficiency virus at screening.
5. Clinically significant abnormal vital signs at screening.
6. Evidence of severe retinopathy by fundoscopy except age-related macular degeneration at screening.
7. 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.
8. Pregnant or breast feeding female subjects.
9. 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.
10. Use of an investigational drug or participation in an investigational drug trial within 4 weeks from the first dose.
11. 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.
12. Hospital Anxiety and Depression Scale (HADS) score \>10 on depression scale at screening that indicates clinically significant presence of depression determined by investigators.
13. Clinically significant presence of severe neurological disorders, e.g. uncontrolled seizure disorders.
14. 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.
15. 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;
16. Body organ transplant and are taking immunosuppressants;
17. 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.
18. History of or ongoing opportunistic infection.
19. Serious local infection or systemic infection within the 3 months prior to screening.

Primary outcomes:
measure: Subjects with undetectable serum HCV RNA at follow up week 12
timeFrame: Follow Week 12
Secondary outcomes:
measure: Subjects with undetectable serum HCV RNA
timeFrame: Treatment Week 4, 8, 12, 24 and Follow Week 24
measure: Number of subjects with adverse events
timeFrame: Through study Follow Week 24
measure: Number of subjects with clinically significant laboratory abnormalities
timeFrame: Through study Follow Week 24
measure: Subjects with anti-drug antibodies
timeFrame: Follow Week 12 and 24
measure: Subjects with neutralizing antibody
timeFrame: Follow Week 12 and 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital Capital Medical University
city: Gansu
country: China
facility: Gansu Wuwei Tumour Hospital
city: Gansu
country: China
facility: The First Hospital of Lanzhou University
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
city: Henan
country: China
facility: Henan Provincial People's Hospital
city: Henan
country: China
facility: Luoyang Central Hospital
city: Jilin
country: China
facility: The First Hospital of Jilin University
city: Shanxi
country: China
facility: Peace Hospital Affiliated to Changzhi Medical College
city: Shenyang
country: China
facility: The Sixth People's Hospital of Shenyang
city: Xi'an
country: China
facility: Tangdu Hospital, Fourth Military Medical University
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
city: Xi'an
country: China
facility: Xijing Hospital, Fourth Military Medical University
city: Asan
country: Korea, Republic of
facility: Soonchunhyang University Seoul Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Medical Center
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government - Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University Gangnam Severance Hospital
city: Suwon
country: Korea, Republic of
facility: Saint Vincent Catholic Hospital
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital
city: Chiayi City
country: Taiwan
facility: Chang Gung Memorial Hospital, Chiayi Branch
city: Chiayi City
country: Taiwan
facility: Chia-Yi Christian Hospital
city: Chiayi City
country: Taiwan
facility: Dalin Tzu Chi Hospital
city: Chiayi City
country: Taiwan
facility: St. Martin De Porres Hospital
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Memorial Hospital, Kaohsiung Branch
city: Kaohsiung City
country: Taiwan
facility: E-Da Hospital
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital, Keelung Branch
city: New Taipei City
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
city: Taichung City
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan City
country: Taiwan
facility: Chi Mei Hospital, Liouying
city: Tainan City
country: Taiwan
facility: Chi Mei Medical Center
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taitung
country: Taiwan
facility: Taitung MacKay Memorial Hospital
city: Yuanlin
country: Taiwan
facility: National Taiwan University Hospital Yun-Lin Branch
Study officials:
affiliation: PharmaEssentia
name: Yi-Wen Huang, MD/PhD
role: STUDY_DIRECTOR
References: