Loading clinical trials...

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

COMPLETEDPHASE1

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

An Open-label Study to Assess the Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis With HCV Genotype 2 Infection

NCT04774107•PharmaEssentia

View on ClinicalTrials.gov

Summary

Primary Objective: To determine the P1101 pharmacokinetic (PK) profile at the single dose of 400 μg.

Detailed Description

Secondary Objective: To determine the safety and immunogenicity of P1101 400 μg subcutaneous (SC) single dose + Ribavirin 800-1400 mg PO daily.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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.
•3. Compensated liver disease defined by normal or elevated alanine transaminase (ALT) ≤10 x upper limit of normal (ULN), total bilirubin level \<2 mg/dL (except in Gilbert's syndrome), normal albumin, normal international normalized ratio (INR)
•4. Interferon treatment naïve: never received any interferon.
•5. No other known form of chronic liver disease apart from chronic hepatitis C infection.
•6. Hemoglobin 12 g/dL in men or 11 g/dL in women, white blood cell (WBC) count 3,000/mm3, absolute neutrophil count (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

•1. Decompensated liver disease.
•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 HBsAg or HIV at screening.
•5. Clinically significant abnormal vital signs.
•6. Evidence of severe retinopathy by fundoscopy except age-related macular degeneration.
•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.
•10. Use of an investigational drug or participation in an investigational drug.
+9 more criteria

Locations (5)

Chang Gung Memorial Hospital, Chiayi Branch

Chiayi City, Taiwan

Chia-Yi Christian Hospital

Chiayi City, Taiwan

St. Martin De Porres Hospital

Chiayi City, Taiwan

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Chi Mei Medical Center

Tainan, Taiwan

Key Dates

Start Date

November 26, 2020

Primary Completion Date

July 18, 2022

Completion Date

July 18, 2022

Last Updated

August 30, 2022

Enrollment

ACTUAL participants

Conditions

Hepatitis C, Chronic

Interventions

P1101 + Ribavirin

DRUG

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: August 30, 2022Data 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

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

Evaluating the Chain of Addiction Care (CAC)