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COMPLETEDPHASE2

This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis C

An Open-label, Ascending Dose, Phase II Study to Evaluate Tolerability, Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA in Combination With BI 201335 NA and Ribavirin for 8 Weeks in Treatment-naïve Japanese Patients With Genotype 1chronic Hepatitis C Virus Infection

NCT01528735•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

The objective of this trial is to investigate tolerability, safety, pharmacokinetics and antiviral activity of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8 weeks in Japanese treatment-naive patients with chronic GT-1 HCV infection.

Eligibility

Age

20 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Chronic hepatitis C, diagnosed by positive anti-hepatitis C virus(HCV) antibodies and detected HCV ribonucleic acid(RNA) at screening in addition to:
•1. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or,
•2. liver biopsy consistent with chronic HCV infection.
•HCV infection of genotype 1 confirmed by genotypic testing at screening
•Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection.
•Plasma HCV RNA = 100,000 IU/mL at screening

Exclusion Criteria

•Hepatitis C infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
•Human immunodeficiency virus (HIV) co-infection
•Decompensated liver disease, or history of decompensated liver disease
•Body weight \< 40 or \> 125 kg at screening
•Hemoglobin \<12.0g/dL for women and \<13.0g/dL for men at screening
•White blood cell count \<3000 cells/mm3 at screening
•Absolute neutrophil count \< 1,500 cells/mm3 at screening
•Platelet count \< 90,000 /mm3 at screening
•Serum creatinine \> 1.5xUpper Limit of Normal range(ULN) or creatinine clearance =50 mL/min at screening

Locations (5)

1241.25.002 Boehringer Ingelheim Investigational Site

Kofu, Yamanashi, Japan

1241.25.005 Boehringer Ingelheim Investigational Site

Kurashiki, Okayama, Japan

1241.25.003 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

1241.25.004 Boehringer Ingelheim Investigational Site

Nishinomiya, Hyogo, Japan

1241.25.001 Boehringer Ingelheim Investigational Site

Omura, Nagasaki, Japan

Key Dates

Start Date

February 1, 2012

Primary Completion Date

August 1, 2013

Completion Date

August 1, 2013

Last Updated

April 13, 2016

Enrollment

ACTUAL participants

Conditions

Hepatitis C, Chronic

Interventions

BI 207127 NA

DRUG

peginterferon

DRUG

Ribavirin

DRUG

Ribavirin

DRUG

BI 207127 NA

DRUG

BI 201335 NA

DRUG

BI 201335 NA

DRUG

peginterferon

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

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COMPLETEDPHASE4

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

NCT03987503

Hepatitis C, Chronic

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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: April 13, 2016Data 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.

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This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis C

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