MedDataX Logo

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

NCT ID: NCT01528735

Last Updated: 2016-04-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase III Study of BI201335 in Treatment-naive and Prior Relapser Patients With Chronic Hepatitis C Infection

NCT01608737

Hepatitis C, Chronic
WITHDRAWN PHASE3

Japanese Pegylated Interferon (PegIFN) Alfa-2b/Ribavirin (RBV) Combination Trial

NCT01579474

Hepatitis C
COMPLETED PHASE3

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

NCT01132313

Hepatitis C, Chronic
COMPLETED PHASE2

Multiple Oral Doses of BI 207127 NA in Treatment naïve and Treatment-experienced Hepatitis C Virus (HCV)-Infected Patients

NCT02176525

Hepatitis C, Chronic
COMPLETED PHASE1

Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced

NCT00793793

Hepatitis C, Chronic
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis C, Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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

Group Type EXPERIMENTAL

peginterferon

Intervention Type DRUG

per package insert

Ribavirin

Intervention Type DRUG

per weight BID

BI 207127 NA

Intervention Type DRUG

one fix dose

BI 201335 NA

Intervention Type DRUG

high dose

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

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

Group Type EXPERIMENTAL

BI 207127 NA

Intervention Type DRUG

one fix dose

Ribavirin

Intervention Type DRUG

per weight BID

BI 201335 NA

Intervention Type DRUG

low dose

peginterferon

Intervention Type DRUG

per package insert

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BI 207127 NA

one fix dose

Intervention Type DRUG

peginterferon

per package insert

Intervention Type DRUG

Ribavirin

per weight BID

Intervention Type DRUG

Ribavirin

per weight BID

Intervention Type DRUG

BI 207127 NA

one fix dose

Intervention Type DRUG

BI 201335 NA

high dose

Intervention Type DRUG

BI 201335 NA

low dose

Intervention Type DRUG

peginterferon

per package insert

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

1241.25.002 Boehringer Ingelheim Investigational Site

Kofu, Yamanashi, , Japan

Site Status

1241.25.005 Boehringer Ingelheim Investigational Site

Kurashiki, Okayama, , Japan

Site Status

1241.25.003 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

Site Status

1241.25.004 Boehringer Ingelheim Investigational Site

Nishinomiya, Hyogo, , Japan

Site Status

1241.25.001 Boehringer Ingelheim Investigational Site

Omura, Nagasaki, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

Yatsuhashi H, Kodani N, Ugai H, Omata M. Open-label phase 2 study of faldaprevir, deleobuvir and ribavirin in Japanese treatment-naive patients with chronic hepatitis C virus genotype 1 infection. Hepatol Res. 2016 Mar;46(3):E189-93. doi: 10.1111/hepr.12535. Epub 2015 Jun 18.

Reference Type DERIVED
PMID: 25991083 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1241.25

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

4 Week Combination of BI 207127 NA With Peg-IFN and Ribavirin in Chronic HCV Patients
NCT00905632 COMPLETED PHASE1
Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients
NCT01525628 COMPLETED PHASE1
A Phase III Study of TMC435 in Genotype 1, Hepatitis C-infected Participants Who Failed to Respond to Previous IFN-based Therapy
NCT01288209 COMPLETED PHASE3
Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients
NCT01858961 WITHDRAWN PHASE3
A Study of TMC435 in Genotype 1, Hepatitis C-infected Patients Who Relapsed After Previous Interferon (IFN)-Based Therapy
NCT01290731 COMPLETED PHASE3
A Study of TMC435 in Participants With Genotype 1 Hepatitis C Virus (HCV) Infection
NCT01366638 COMPLETED PHASE3
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 PHASE2
A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection
NCT01672983 COMPLETED PHASE2
Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects
NCT01563536 COMPLETED PHASE2
Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)
NCT00686517 COMPLETED PHASE3
Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2
NCT01728324 COMPLETED PHASE3
A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients
NCT01292239 COMPLETED PHASE3
Drug Use-Results Survey in Participants Infected With Hepatitis C Virus Genotype 2
NCT02945228 COMPLETED
A Study to Evaluate the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C
NCT00332176 UNKNOWN PHASE2
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection
NCT02707952 COMPLETED PHASE3
Study of Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Relapsed After Treatment (MK-7009-044)
NCT01405937 COMPLETED PHASE3
Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection
NCT02023112 COMPLETED PHASE3
Study of Ombitasvir/Paritaprevir/Ritonavir in Japanese Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection With End Stage Renal Disease (ESRD) on Hemodialysis (HD)
NCT02806362 WITHDRAWN PHASE3
IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1
NCT01732796 COMPLETED PHASE3
A Study to Assess the Effectiveness, Safety, and Pharmacokinetics of TMC435 in Combination With Peginterferon Alfa-2a and Ribavirin in Hepatitis-C Infected Patients
NCT00996476 COMPLETED PHASE2
Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care
NCT01012895 COMPLETED PHASE2
A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment
NCT00882908 COMPLETED PHASE2
A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients
NCT01497834 COMPLETED PHASE3
Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C
NCT01859962 COMPLETED PHASE2
A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016)
NCT00880763 COMPLETED PHASE2