Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Hepatitis C; Pharmacokinetics

Treatments: Drug: BI 201335 NA high; Drug: BI 201335 NA low; Drug: BI 201335 NA high placebo; Drug: pegylated interferon (PegIFN) alfa-2a; Drug: ribavirin (RBV); Drug: Placebo; Drug: BI 201335 NA low placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00947349

1220.14

Details and patient eligibility

About

The current Standard of Care (SOC) for chronic HCV infection, which is pegylated interferon-alfa as combination therapy with ribavirin for 24-48 weeks of treatment, is effective in only part of the patients and is often associated with severe adverse effects leading to discontinuation of treatment and dose modifications.

A number of compounds with direct activity are currently under clinical development, incl. BI 201335. BI 201335 works by preventing the Hepatitis C virus from replicating by binding to the HCV protease (enzyme). The main purpose of this clinical trial with BI 201335 is to see how well BI 201335 works and how safe BI 201335 is to use daily in combination with PegIFN and RBV in HCV infected patients

Enrollment: 22 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• chronic HCV genotype-1;
• high viral load

Exclusion criteria

• Mixed genotype (1/2, 1/3, or 1/4), diagnosed by genotypic testing at screening
• Previous treatment with protease inhibitor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 4 patient groups, including a placebo group

BI 201335 NA low TN

Experimental group

Description:

patient to receive a capsule containing low dose of BI 201335 NA/Drug for treatment-naive (TN) patients

Treatment:

Drug: BI 201335 NA low

Drug: pegylated interferon (PegIFN) alfa-2a

Drug: pegylated interferon (PegIFN) alfa-2a

Drug: ribavirin (RBV)

Drug: ribavirin (RBV)

Drug: ribavirin (RBV)

Drug: BI 201335 NA low placebo

Drug: pegylated interferon (PegIFN) alfa-2a

BI 201335 NA high TN

Experimental group

Description:

patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-naive (TN )patients

Treatment:

Drug: pegylated interferon (PegIFN) alfa-2a

Drug: pegylated interferon (PegIFN) alfa-2a

Drug: ribavirin (RBV)

Drug: ribavirin (RBV)

Drug: BI 201335 NA high placebo

Drug: ribavirin (RBV)

Drug: BI 201335 NA high

Drug: BI 201335 NA high

Drug: pegylated interferon (PegIFN) alfa-2a

BI 201335 NA high TE

Experimental group

Description:

patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-experienced (TE) patients

Treatment:

Drug: pegylated interferon (PegIFN) alfa-2a

Drug: pegylated interferon (PegIFN) alfa-2a

Drug: ribavirin (RBV)

Drug: ribavirin (RBV)

Drug: ribavirin (RBV)

Drug: BI 201335 NA high

Drug: BI 201335 NA high

Drug: pegylated interferon (PegIFN) alfa-2a

Placebo in Treatment Naive (TN) Patients

Placebo Comparator group

Treatment:

Drug: Placebo