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

NCT00947349 | Completed Phase 2 Results

• 1 other identifier: 1220.14
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Hepatitis C; Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy

  Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.

  4 weeks

• Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy

  Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in triple combination therapy for treatment naive patients and treatment experienced patients.

  4 weeks

• Assessment of Tolerability in Triple Combination Therapy

  An assessment of tolerability for the safety of the triple combination therapy with BI 201335 NA, PegIFN α -2a and RBV.

  4 weeks

Secondary Outcomes (30)

• Week 2 Virological Response (W2VR)

  2 weeks

• Week 4 Virological Response (W4VR)

  4 weeks

• Rapid Virological Response (RVR)

  4 weeks

• Change From Baseline in HCV Viral Load

  baseline and week 4

• Day 28 Virologic Response

  4 weeks

Study Arms (4)

BI 201335 NA low TN

EXPERIMENTAL

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

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

BI 201335 NA high TN

EXPERIMENTAL

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

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

BI 201335 NA high TE

EXPERIMENTAL

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

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

Placebo in Treatment Naive (TN) Patients

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ribavirin (RBV) DRUG

ribavirin (RBV)

BI 201335 NA high TN

pegylated interferon (PegIFN) alfa-2a DRUG

pegylated interferon (PegIFN) alfa-2a

BI 201335 NA low TN

BI 201335 NA low placebo DRUG

Placebo

BI 201335 NA low TN

BI 201335 NA high DRUG

BI 201335 NA high

BI 201335 NA high TN

BI 201335 NA low DRUG

BI 201335 NA

BI 201335 NA low TN

BI 201335 NA high placebo DRUG

placebo

BI 201335 NA high TN

Placebo DRUG

Placebo in Treatment Naive (TN) Patients

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic HCV genotype-1;
• high viral load

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (3)

1220.14.003 Boehringer Ingelheim Investigational Site

Kurashiki, Okayama, Japan

Location

1220.14.001 Boehringer Ingelheim Investigational Site

Minato-ku, Tokyo, Japan

Location

1220.14.002 Boehringer Ingelheim Investigational Site

Nishinomiya, Hyogo, Japan

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

Additional secondary endpoints were listed in the original protocol. Those endpoints are of exploratory nature only and were not considered relevant for trial conclusions. For more information see tab "Full Text Review", section "More Information".

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 28, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 7, 2015
• Results First Posted: July 7, 2015

Record last verified: 2015-07

Locations

JP (3)