Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection

Summary

The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating.

The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV.

A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa.

This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and Part 3.

Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated: 362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83 patients randomized and treated)

Conditions

• Hepatitis C, Chronic

Interventions

DRUG

BI 207127

28 weeks, high dose, TID

DRUG

BI 201335

40 weeks, QD

DRUG

BI 207127

4 weeks, low dose TID

DRUG

BI 201335

24 weeks, QD

DRUG

Ribavirin

16 weeks, according to label

DRUG

Ribavirin

28 weeks, according to label

DRUG

Ribavirin

28 weeks, according to label

DRUG

BI 207127

40 weeks, high dose, TID

DRUG

BI 207127

24 weeks, very high dose, BID

DRUG

BI 207127

16 weeks, standard dose, BID

DRUG

BI 201335

24 weeks, QD

DRUG

Ribavirin

48 weeks, according to label

DRUG

Ribavirin

40 weeks, according to label

DRUG

BI 207127

16 weeks, high dose, TID

DRUG

BI 207127

28 weeks, high dose, TID

DRUG

BI 201335

28 weeks, QD

DRUG

BI 201335

16 weeks, QD

DRUG

Ribavirin

24 weeks, according to label

DRUG

BI 201335

24 weeks, QD

DRUG

BI 201335

28 weeks, QD

DRUG

BI 207127

24 weeks, standard dose, BID

DRUG

BI 201335

24 weeks, QD

DRUG

BI 201335

16 weeks, QD

DRUG

BI 207127

16 weeks, high dose, BID

DRUG

BI 201335

24 weeks, QD

DRUG

Ribavirin

16 weeks, according to label

DRUG

Ribavirin

16 weeks, according to label

DRUG

BI 207217

28 weeks, high dose BID

DRUG

BI 201335

16 weeks, QD

DRUG

BI 207127

24 weeks, high dose, TID

DRUG

Ribavirin

48 weeks, according to label

DRUG

BI 207127

4 weeks, high dose, TID

DRUG

BI 201335

28 weeks, QD

DRUG

Ribavirin

24 weeks, according to label

DRUG

Ribavirin

24 weeks, according to label

Sponsors & Collaborators

• Boehringer Ingelheim

  lead INDUSTRY

Principal Investigators

• Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2014-10-31

Completion

2014-10-31

Countries

• United States
• Australia
• Austria
• France
• Germany
• New Zealand
• Portugal
• Romania
• Spain
• Switzerland

Study Locations