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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

NCT01528735 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-04-13

Study results available
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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.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

BI 207127 NA

one fix dose

DRUG

peginterferon

per package insert

DRUG

Ribavirin

per weight BID

DRUG

Ribavirin

per weight BID

DRUG

BI 207127 NA

one fix dose

DRUG

BI 201335 NA

high dose

DRUG

BI 201335 NA

low dose

DRUG

peginterferon

per package insert

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Japan

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01528735 on ClinicalTrials.gov