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

NCT01579474 | Completed Phase 3 Results

• 1 other identifier: 1220.54
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 24

Brief Summary

The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24 weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1 hepatitis C virus infected treatment-naïve and treatment-experienced Japanese patients

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Investigator Defined Drug-related Adverse Events

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

  Up to 52 weeks

Secondary Outcomes (11)

• Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)

  EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)

• Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT)

  EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)

• Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8

  up to 8 weeks

• Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES

  EOT (up to Week 24 or 48)

• Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO

  EOT (up to Week 24 or 48)

Study Arms (4)

1. BI 201335 low dose plus PegIFN/RBV

EXPERIMENTAL

low dose BI 201335 NA once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients

Drug: BI 201335 low dose

2. BI 201335 high dose plus PegIFN/RBV

EXPERIMENTAL

high dose BI 201335 NA once daily for 12 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients

Drug: BI 201335 high dose

3. BI 201335 high dose plus PegIFN/RBV

EXPERIMENTAL

high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients

Drug: BI 201335 high dose

4. BI 201335 high dose plus PegIFN/RBV

EXPERIMENTAL

high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 48 weeks in treatment-experienced (null responder, partial responder, breakthrough) patients

Drug: BI 201335 high dose

Interventions

BI 201335 high dose DRUG

BI 201335 high dose with PegIFN/RBV

2. BI 201335 high dose plus PegIFN/RBV

BI 201335 low dose DRUG

BI 201335 low dose with PegIFN/RBV

1. BI 201335 low dose plus PegIFN/RBV

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 hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to:
• positive anti-HCV antibodies or detected HCV RNA at least 6 months before screening; or,
• liver biopsy consistent with chronic HCV infection.
• HCV genotype 1 infection confirmed by genotypic testing at screening
• (For Cohort 1 only) Therapy-naïve to interferon, pegylated interferon, and ribavirin (For Cohort 2 only) Confirmed prior virological failure (null response, partial response, breakthrough or relapse) with an approved dose of PegIFN alfa/RBV or IFN beta/RBV for at least 12 weeks and with an 8-week washout period before screening
• HCV RNA = 100,000 IU/mL at screening
• Documentation of a liver biopsy within 3 years or fibroscan within 6 months before randomization (Visit 2)
• Age 20 to 70 years
• Female patients who are infertile or who are of childbearing potential with a negative pregnancy test and agreeing to use one accepted method of birth control in addition to the use of a condom by their male partners.
• or Male patients who are infertile, who are without pregnant female partners or who consistently and correctly use condoms.
• Signed informed consent form before trial participation

You may not qualify if:

• HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening,
• HIV co-infection,
• Hepatitis B virus (HBV) infection based on presence of hepatitis B surface antigen (HBsAg),
• Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix),
• Active or, history of alcohol or illicit drug abuse within the past 12 months,
• A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patient's ability to participate in this study,
• Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study,
• Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to screening. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened,
• Received silymarin (milk thistle), glycyrrhizin (Stronger Neo-Minophagen C; SNMC), or Sho-saiko-to (SST) within 28 days prior to randomization (Visit 2) and throughout the treatment phase of this trial,
• (For Cohort 2 only) Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than (pegylated) interferon alfa, interferon beta or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors,
• Known hypersensitivity to any ingredient of the study drugs,
• Alpha fetoprotein value \>100 ng/mL at screening; if \>20 ng/mL and =100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2),

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (24)

1220.54.08104 Boehringer Ingelheim Investigational Site

Chuo-ku, Chiba, Japan

Location

1220.54.08118 Boehringer Ingelheim Investigational Site

Chuo-ku, Kobe, Hyogo, Japan

Location

1220.54.08108 Boehringer Ingelheim Investigational Site

Fukui, Fukui, Japan

Location

1220.54.08110 Boehringer Ingelheim Investigational Site

Gifu, Gifu, Japan

Location

1220.54.08105 Boehringer Ingelheim Investigational Site

Itabashi-ku, Tokyo, Japan

Location

1220.54.08112 Boehringer Ingelheim Investigational Site

Izunokuni, Shizuoka, Japan

Location

1220.54.08107 Boehringer Ingelheim Investigational Site

Kanazawa, Ishikawa, Japan

Location

1220.54.08120 Boehringer Ingelheim Investigational Site

Kita-gun, Kagawa, Japan

Location

1220.54.08109 Boehringer Ingelheim Investigational Site

Kofu, Yamanashi, Japan

Location

1220.54.08123 Boehringer Ingelheim Investigational Site

Kurume, Fukuoka, Japan

Location

1220.54.08121 Boehringer Ingelheim Investigational Site

Mtsuyama, Ehime, Japan

Location

1220.54.08113 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1220.54.08117 Boehringer Ingelheim Investigational Site

Nishinomiya, Hyogo, Japan

Location

1220.54.08111 Boehringer Ingelheim Investigational Site

Ogaki, Gifu, Japan

Location

1220.54.08124 Boehringer Ingelheim Investigational Site

Oo Mura, Nagasaki,, Japan

Location

1220.54.08115 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1220.54.08116 Boehringer Ingelheim Investigational Site

Osakasayama, Osaka, Japan

Location

1220.54.08101 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1220.54.08102 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, Japan

Location

1220.54.08119 Boehringer Ingelheim Investigational Site

Tanabe, Wakayama, Japan

Location

1220.54.08106 Boehringer Ingelheim Investigational Site

Toyama,Toyama, Japan

Location

1220.54.08114 Boehringer Ingelheim Investigational Site

Tsu, Mie, Japan

Location

1220.54.08122 Boehringer Ingelheim Investigational Site

Yahatanishi-ku, Kitakyusyu, Fukuoka, Japan

Location

1220.54.08125 Boehringer Ingelheim Investigational Site

Yamagata, Yamagata, Japan

Location

Related Publications (1)

• Nishiguchi S, Urano Y, Suzaki K, Taniguchi A, Scherer J, Berger KL, Quinson AM, Stern JO, Omata M. Safety and efficacy of faldaprevir in combination with pegylated interferon alpha-2b and ribavirin in Japanese patients with genotype-1 chronic hepatitis C virus infection. Hepatol Res. 2017 Mar;47(3):E142-E151. doi: 10.1111/hepr.12741. Epub 2016 Aug 10.

  PMID: 27153246 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

faldaprevir

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

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: April 18, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 3, 2015
• Results First Posted: August 3, 2015

Record last verified: 2015-07

Locations

JP (24)