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Dose Finding Study of Pegylated-P-Interferon-alpha-2b(P1101) in Treatment-Naive Subjects With Hepatitis C Virus Genotype 1 Infection | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Dose Finding Study of Pegylated-P-Interferon-alpha-2b(P1101) in Treatment-Naive Subjects With Hepatitis C Virus Genotype 1 Infection

An Open-label, Randomized, Active Control Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of P1101 + Ribavirin in Treatment-Naïve Subjects With HCV Genotype 1 Infection

NCT01587586•PharmaEssentia

View on ClinicalTrials.gov

Summary

Primary objectives: The purpose of this study is to determine and compare the sustained virologic response (SVR, undetectable HCV RNA at Follow up week 24 (FW24)) across treatment groups. To determine and compare the safety and tolerability of P1101 + Ribavirin across treatment groups.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults ≥18 years of age (≥ 20 years for subjects enrolled in Taiwan); subjects who are over 70 years of age must be in generally good health.
•Confirmed diagnosis of chronic hepatitis C (CHC) virus genotype 1 infection: (1) Positive for anti-HCV antibody or HCV RNA at least 6 months before screening, and positive for HCV RNA genotype 1 or anti-HCV antibody at the time of screening; or (2) Positive for anti-HCV antibody or HCV RNA genotype 1 at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of CHC disease, such as the presence of fibrosis).
•Compensated liver disease: with normal or elevated alanine aminotransaminase (ALT)/ aspartate aminotransferase (AST) (≤ 5 times the upper limit of normal), normal bilirubin level (\< 2 mg/dL, except for Gilbert's syndrome), normal albumin, normal prothrombin time (PT) (INR\< 1.3), no clinical symptoms or signs of cirrhosis or liver decompensation, and no evidence of cirrhosis as identified by ultrasound or any other procedures within 6 months before study entry.
•Treatment naïve: never received interferon, ribavirin or any other HCV treatment.
•No other form of chronic liver disease apart from chronic hepatitis C infection.
•Hemoglobin ≥ 13 g/dL in men or ≥ 12 g/dL in women, white blood cell (WBC) count ≥ 3,500/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, platelet count ≥ 90,000/mm3; renal biochemistry estimated glomerular filtration rate (eGFR) \> 60 mL/min.
•Be able to attend all scheduled visits and to comply with all study procedures.
•Be able to provide written informed consent.

Exclusion Criteria

•Clinically significant illness or surgery within 4 weeks prior to dosing.
•Any clinically significant abnormality or abnormal laboratory test results found during medical screening besides serum ALT/AST (≤ 5 times the upper limit of normal).
•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 (HBsAg) or human immunodeficiency virus (HIV) at screening.
•Clinically significant vital sign abnormalities at screening.
•Significant or major fundoscopic findings including but not limited to retinal exudates, hemorrhage, detachment, neovascularization, papilloedema, optic atrophy, microaneurysms and macular changes.
•History of significant alcohol or drug abuse within one year prior to the screening visit (alcohol consumption of more than fourteen units of alcohol per week \[1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol\]) or refusal to abstain from alcohol or illicit drugs throughout the study.
•Pregnancy or, in women of child-bearing potential or in spouses of such women, unwillingness or inability to practice adequate contraception, defined as vasectomy in men, tubal ligation in women, or use of condoms and spermicides, or birth control pills, or intrauterine devices throughout the study.
•History of severe allergic or hypersensitivity reactions (like angioedema), specifically asthma, any known reaction to the study medication, allergic skin rash or other allergic reactions (like anaphylaxis), including severe drug allergies.
•Therapy with any systemic anti-viral, anti-neoplastic, and immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) within 6 months prior to the first dose of study drug.
+10 more criteria

Locations (13)

Changhua Christian Hospital

Changhua, Taiwan

National Taiwan University Hospital - Yunlin

Douliu, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Chang Gung Medical Foundation - Kaohsiung

Kaohsiung City, Taiwan

Chang Gung Medical Foundation - Keelung

Keelung, Taiwan

Chang Gung Medical Foundation - Linkou

Linkou District, Taiwan

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Buddhist Tzu Chi General Hospital

Sindian City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Key Dates

Start Date

October 18, 2011

Primary Completion Date

November 22, 2016

Completion Date

November 22, 2016

Last Updated

October 15, 2021

Enrollment

107

ACTUAL participants

Conditions

Hepatitis C, Chronic

Interventions

PEGASYS 180 µg Q1W

BIOLOGICAL

P1101 180 µg Q1W, 48 doses

BIOLOGICAL

P1101 270µg Q1W, 48 doses

BIOLOGICAL

P1101 450µg Q2W, 24 doses

BIOLOGICAL

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

NCT05870969

Carcinoma, HepatocellularHepatitis C, Chronic+3 more

View study

COMPLETEDPHASE4

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

NCT03987503

Hepatitis C, Chronic

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 15, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Dose Finding Study of Pegylated-P-Interferon-alpha-2b(P1101) in Treatment-Naive Subjects With Hepatitis C Virus Genotype 1 Infection

Inclusion Criteria

Exclusion Criteria

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir

Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes

Addition of ISIS 14803 to Therapy With Peginterferon and Ribavirin for Chronic Hepatitis C (HCV) Patients Not Responding Adequately to the Two Drugs

The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection