Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection

NCT ID: NCT04382937

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-12
• Study Completion Date: 2020-07-15

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

Conditions

Chronic Hepatitis C Virus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

P1101 + Ribavirin

P1101 400 µg SC Q2W

Group Type: EXPERIMENTAL

P1101 + Ribavirin

Intervention Type: DRUG

P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily

PEG-Intron + Ribavirin

PEG-Intron 1.5 µg per kg SC Q1W

Group Type: ACTIVE_COMPARATOR

PEG-Intron + Ribavirin

Intervention Type: DRUG

PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily

Interventions

P1101 + Ribavirin

P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily

Intervention Type: DRUG

PEG-Intron + Ribavirin

PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily

Intervention Type: DRUG

Other Intervention Names

Ropeginterferon alfa-2b; Peginterferon alfa-2b

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PharmaEssentia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi-Wen Huang, MD/PhD

Role: STUDY_DIRECTOR

PharmaEssentia

Locations

Beijing Ditan Hospital Capital Medical University

Beijing, , China

Gansu Wuwei Tumour Hospital

Gansu, , China

The First Hospital of Lanzhou University

Gansu, , China

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, , 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

Soonchunhyang University Seoul Hospital

Asan, , South Korea

Pusan National University Hospital

Busan, , South Korea

Kyungpook National University Hospital

Daegu, , South Korea

Inha University Medical Center

Incheon, , South Korea

Hanyang University Seoul Hospital

Seoul, , South Korea

Seoul Metropolitan Government - Seoul National University Boramae Medical Center

Seoul, , South Korea

Yonsei University Gangnam Severance Hospital

Seoul, , South Korea

Saint Vincent Catholic Hospital

Suwon, , South Korea

Changhua Christian Hospital

Changhua, , Taiwan

Chang Gung Memorial Hospital, Chiayi Branch

Chiayi City, , Taiwan

Chia-Yi Christian Hospital

Chiayi City, , Taiwan

Dalin Tzu Chi Hospital

Chiayi City, , Taiwan

St. Martin De Porres Hospital

Chiayi City, , Taiwan

Hualien Tzu Chi Hospital

Hualien City, , Taiwan

Chang Gung Memorial Hospital, Kaohsiung Branch

Kaohsiung City, , Taiwan

E-Da Hospital

Kaohsiung City, , Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Chang Gung Memorial Hospital, Keelung Branch

Keelung, , Taiwan

Chang Gung Memorial Hospital, Linkou

New Taipei City, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

Chi Mei Hospital, Liouying

Tainan City, , Taiwan

Chi Mei Medical Center

Tainan City, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taitung MacKay Memorial Hospital

Taitung, , Taiwan

National Taiwan University Hospital Yun-Lin Branch

Yuanlin, , Taiwan

Countries

China; South Korea; Taiwan

Other Identifiers

A14-301

Identifier Type: -

Identifier Source: org_study_id