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

NCT ID: NCT01579474

Last Updated: 2015-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1. BI 201335 low dose plus PegIFN/RBV

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

Group Type: EXPERIMENTAL

BI 201335 low dose

Intervention Type: DRUG

BI 201335 low dose with PegIFN/RBV

2. BI 201335 high dose plus PegIFN/RBV

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

Group Type: EXPERIMENTAL

BI 201335 high dose

Intervention Type: DRUG

BI 201335 high dose with PegIFN/RBV

3. BI 201335 high dose plus PegIFN/RBV

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

Group Type: EXPERIMENTAL

BI 201335 high dose

Intervention Type: DRUG

BI 201335 high dose with PegIFN/RBV

4. BI 201335 high dose plus PegIFN/RBV

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

Group Type: EXPERIMENTAL

BI 201335 high dose

Intervention Type: DRUG

BI 201335 high dose with PegIFN/RBV

Interventions

BI 201335 high dose

BI 201335 high dose with PegIFN/RBV

Intervention Type: DRUG

BI 201335 low dose

BI 201335 low dose with PegIFN/RBV

Intervention Type: DRUG

BI 201335 high dose

BI 201335 high dose with PegIFN/RBV

Intervention Type: DRUG

BI 201335 high dose

BI 201335 high dose with PegIFN/RBV

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

2. HCV genotype 1 infection confirmed by genotypic testing at screening

3. (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

4. HCV RNA = 100,000 IU/mL at screening

5. Documentation of a liver biopsy within 3 years or fibroscan within 6 months before randomization (Visit 2)

6. Age 20 to 70 years

7. 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.

8. Signed informed consent form before trial participation

Exclusion Criteria

1. HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening,

2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Steatosis diagnosed incidentally (e.g. by biopsy) without clinical relevance is not an exclusion criterion.

3. HIV co-infection,

4. Hepatitis B virus (HBV) infection based on presence of hepatitis B surface antigen (HBsAg),

5. 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),

6. Active or, history of alcohol or illicit drug abuse within the past 12 months,

7. 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,

8. Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study,

9. 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,

10. 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,

11. (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,

12. Known hypersensitivity to any ingredient of the study drugs,

13. 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),

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1220.54.08104 Boehringer Ingelheim Investigational Site

Chuo-ku, Chiba, , Japan

1220.54.08118 Boehringer Ingelheim Investigational Site

Chuo-ku, Kobe, Hyogo, , Japan

1220.54.08108 Boehringer Ingelheim Investigational Site

Fukui, Fukui, , Japan

1220.54.08110 Boehringer Ingelheim Investigational Site

Gifu, Gifu, , Japan

1220.54.08105 Boehringer Ingelheim Investigational Site

Itabashi-ku, Tokyo, , Japan

1220.54.08112 Boehringer Ingelheim Investigational Site

Izunokuni, Shizuoka, , Japan

1220.54.08107 Boehringer Ingelheim Investigational Site

Kanazawa, Ishikawa, , Japan

1220.54.08120 Boehringer Ingelheim Investigational Site

Kita-gun, Kagawa, , Japan

1220.54.08109 Boehringer Ingelheim Investigational Site

Kofu, Yamanashi, , Japan

1220.54.08123 Boehringer Ingelheim Investigational Site

Kurume, Fukuoka, , Japan

1220.54.08121 Boehringer Ingelheim Investigational Site

Mtsuyama, Ehime, , Japan

1220.54.08113 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

1220.54.08117 Boehringer Ingelheim Investigational Site

Nishinomiya, Hyogo, , Japan

1220.54.08111 Boehringer Ingelheim Investigational Site

Ogaki, Gifu, , Japan

1220.54.08124 Boehringer Ingelheim Investigational Site

Oo Mura, Nagasaki,, , Japan

1220.54.08115 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

1220.54.08116 Boehringer Ingelheim Investigational Site

Osakasayama, Osaka, , Japan

1220.54.08101 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

1220.54.08102 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, , Japan

1220.54.08119 Boehringer Ingelheim Investigational Site

Tanabe, Wakayama, , Japan

1220.54.08106 Boehringer Ingelheim Investigational Site

Toyama,Toyama, , Japan

1220.54.08114 Boehringer Ingelheim Investigational Site

Tsu, Mie, , Japan

1220.54.08122 Boehringer Ingelheim Investigational Site

Yahatanishi-ku, Kitakyusyu, Fukuoka, , Japan

1220.54.08125 Boehringer Ingelheim Investigational Site

Yamagata, Yamagata, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 27153246 (View on PubMed)

Other Identifiers

1220.54

Identifier Type: -

Identifier Source: org_study_id