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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: BI 201335 NA; Drug: BI 207127 NA; Drug: peginterferon; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01528735

1241.25

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

BI 207127 NA, BI 201335 NA(high dose), R

Experimental group

Description:

Patients receive BI 207127 NA,BI 201335 NA(high dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

Treatment:

Drug: BI 207127 NA

Drug: peginterferon

Drug: BI 207127 NA

Drug: BI 201335 NA

Drug: Ribavirin

Drug: peginterferon

Drug: Ribavirin

Drug: BI 201335 NA

BI 207127 NA,BI 201335 NA(low dose),RBV

Experimental group

Description:

Patients receive BI 207127 NA,BI 201335 NA(low dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

Treatment:

Drug: BI 207127 NA

Drug: peginterferon

Drug: BI 207127 NA

Drug: BI 201335 NA

Drug: Ribavirin

Drug: peginterferon

Drug: Ribavirin

Drug: BI 201335 NA