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

Hepatitis C, Chronic Clinical Trial

Official title:

An Open-label, Ascending Dose, Phase II Study to Evaluate Tolerability, Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA in Combination With BI 201335 NA and Ribavirin for 8 Weeks in Treatment-naïve Japanese Patients With Genotype 1chronic Hepatitis C Virus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528735
• Other study ID #: 1241.25
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2012
• Last updated: April 30, 2014
• Start date: February 2012
• Est. completion date: August 2013

Study information

• Verified date: April 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• BI 207127 NA
one fix dose
• peginterferon
per package insert
• Ribavirin
per weight BID
• Ribavirin
per weight BID
• BI 207127 NA
one fix dose
• BI 201335 NA
high dose
• BI 201335 NA
low dose
• peginterferon
per package insert

Locations

Country	Name	City	State
Japan	1241.25.002 Boehringer Ingelheim Investigational Site	Kofu, Yamanashi
Japan	1241.25.005 Boehringer Ingelheim Investigational Site	Kurashiki, Okayama
Japan	1241.25.003 Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	1241.25.004 Boehringer Ingelheim Investigational Site	Nishinomiya, Hyogo
Japan	1241.25.001 Boehringer Ingelheim Investigational Site	Omura, Nagasaki

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Secondary	Virological response at Week 4		4 weeks	No
Secondary	Virological response at Week 8		8 weeks	No