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

NCT04382937 | Completed Phase 3 DMC

• 1 other identifier: A14-301
• Study Type: interventional
• Target: 222
• Locations: 3 countries
• Sites: 39

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

Conditions

Chronic Hepatitis C Virus Infection

Keywords

P1101; HCV; PEG-Intron

Outcome Measures

Primary Outcomes (1)

• Subjects with undetectable serum HCV RNA at follow up 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

  Follow Week 12

Secondary Outcomes (5)

• Subjects with undetectable serum HCV RNA

  Treatment Week 4, 8, 12, 24 and Follow Week 24

• Number of subjects with adverse events

  Through study Follow Week 24

• Number of subjects with clinically significant laboratory abnormalities

  Through study Follow Week 24

• Subjects with anti-drug antibodies

  Follow Week 12 and 24

• Subjects with neutralizing antibody

  Follow Week 12 and 24

Study Arms (2)

P1101 + Ribavirin

EXPERIMENTAL

P1101 400 µg SC Q2W

Drug: P1101 + Ribavirin

PEG-Intron + Ribavirin

ACTIVE COMPARATOR

PEG-Intron 1.5 µg per kg SC Q1W

Drug: PEG-Intron + Ribavirin

Interventions

P1101 + Ribavirin DRUG

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

Also known as: Ropeginterferon alfa-2b

P1101 + Ribavirin

PEG-Intron + Ribavirin DRUG

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

Also known as: Peginterferon alfa-2b

PEG-Intron + Ribavirin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• PharmaEssentia: lead

Study Sites (39)

Beijing Ditan Hospital Capital Medical University

Beijing, China

Location

Gansu Wuwei Tumour Hospital

Gansu, China

Location

The First Hospital of Lanzhou University

Gansu, China

Location

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, China

Location

Henan Provincial People's Hospital

Henan, China

Location

Luoyang Central Hospital

Henan, China

Location

The First Hospital of Jilin University

Jilin, China

Location

Peace Hospital Affiliated to Changzhi Medical College

Shanxi, China

Location

The Sixth People's Hospital of Shenyang

Shenyang, China

Location

Tangdu Hospital, Fourth Military Medical University

Xi'an, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

Xijing Hospital, Fourth Military Medical University

Xi'an, China

Location

Soonchunhyang University Seoul Hospital

Asan, South Korea

Location

Pusan National University Hospital

Busan, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Inha University Medical Center

Incheon, South Korea

Location

Hanyang University Seoul Hospital

Seoul, South Korea

Location

Seoul Metropolitan Government - Seoul National University Boramae Medical Center

Seoul, South Korea

Location

Yonsei University Gangnam Severance Hospital

Seoul, South Korea

Location

Saint Vincent Catholic Hospital

Suwon, South Korea

Location

Changhua Christian Hospital

Changhua, Taiwan

Location

Chang Gung Memorial Hospital, Chiayi Branch

Chiayi City, Taiwan

Location

Chia-Yi Christian Hospital

Chiayi City, Taiwan

Location

Dalin Tzu Chi Hospital

Chiayi City, Taiwan

Location

St. Martin De Porres Hospital

Chiayi City, Taiwan

Location

Hualien Tzu Chi Hospital

Hualien City, Taiwan

Location

Chang Gung Memorial Hospital, Kaohsiung Branch

Kaohsiung City, Taiwan

Location

E-Da Hospital

Kaohsiung City, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

Chang Gung Memorial Hospital, Keelung Branch

Keelung, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

New Taipei City, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

Chi Mei Hospital, Liouying

Tainan, Taiwan

Location

Chi Mei Medical Center

Tainan, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taitung MacKay Memorial Hospital

Taitung, Taiwan

Location

National Taiwan University Hospital Yun-Lin Branch

Yuanlin, Taiwan

Location

MeSH Terms

Interventions

Ribavirin; peginterferon alfa-2b

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Yi-Wen Huang, MD/PhD

  PharmaEssentia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 11, 2020
• Study Start: January 12, 2016
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

CN (12); KR (8); TW (19)