A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients

NCT01330316 | Completed Phase 3 Results

• 2 other identifiers: 1220.482011-000141-20
• Study Type: interventional
• Target: 119
• Locations: 15 countries
• Sites: 87

Brief Summary

The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Sustained Virological Response (SVR): Plasma HCV RNA Level < 25 IU/mL

  The primary endpoint was SVR12, defined as a plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level \<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.

  12 weeks post treatment, up to 60 weeks

Secondary Outcomes (15)

• Sustained Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)

  24 weeks post treatment, up to 72 weeks

• Early Treatment Success (ETS)

  week 4 and week 8

• Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT)

  Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers

• Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at 12 Weeks Post-treatment.

  48 weeks for relapsers with ETS; 60 weeks for non-relapsers and relapsers without ETS

• Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT)

  Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers.

Study Arms (1)

BI 201335 for 24 weeks

EXPERIMENTAL

BI 201335 once daily dose for 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks

Drug: BI 201335; Drug: PegIFN/RBV

Interventions

BI 201335 DRUG

BI 201335 for 24 weeks

BI 201335 for 24 weeks

PegIFN/RBV DRUG

PegIFN/RBV for 48 weeks

BI 201335 for 24 weeks

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic hepatitis C infection of GT-1 in patients who failed prior treatment with PegIFN and RBV in the 1220.7, 1220.30 and 1220.47 trials of the BI 201335 Phase III program.
• Patients from trials 1220.7, 1220.30 and 1220.47 of BI 201335 who have failed treatment with PegIFN/RBV in the placebo groups due to protocol-defined criteria of treatment failure (i.e. either non-response on treatment or relapse after end of treatment \[EOT\]).
• Patients must have received at least 4 weeks of assigned trial medication and been compliant with all study procedures.
• Female patients:
• with documented hysterectomy,
• who have had both ovaries removed,
• with documented tubal ligation,
• who are post-menopausal with last menstrual period at least 12 months prior to screening, or
• of childbearing potential with a negative serum pregnancy test at screening and Day 1, that, if sexually active, agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of RBV in addition to the consistent and correct use of a condom. Patients must agree not to breast-feed at any time from the date of screening until 7 months after the last dose of RBV.
• Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance, intra-uterine device and cervical cap.
• Male patients:
• who are documented to be sterile, or
• who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and the observation phase. Female partners of childbearing potential must perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor).
• Signed informed consent form prior to trial participation.

You may not qualify if:

• HIV co-infection
• Hepatitis B virus (HBV) infection based on presence of HBs-Ag
• 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 other than cannabis 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 patients 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, or Sho-saiko-to (SST) within 28 days prior to enrolment and throughout the treatment phase of this trial.
• 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 (87)

1220.48.0004 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

1220.48.0091 Boehringer Ingelheim Investigational Site

North Little Rock, Arkansas, United States

Location

1220.48.0011 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1220.48.0018 Boehringer Ingelheim Investigational Site

Oceanside, California, United States

Location

1220.48.0078 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

1220.48.0095 Boehringer Ingelheim Investigational Site

Palm Harbor, Florida, United States

Location

1220.48.0039 Boehringer Ingelheim Investigational Site

Columbus, Georgia, United States

Location

1220.48.0013 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1220.48.0087 Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

Location

1220.48.0027 Boehringer Ingelheim Investigational Site

Framingham, Massachusetts, United States

Location

1220.48.0065 Boehringer Ingelheim Investigational Site

Springfield, Massachusetts, United States

Location

1220.48.0023 Boehringer Ingelheim Investigational Site

Tupelo, Mississippi, United States

Location

1220.48.0066 Boehringer Ingelheim Investigational Site

Neptune City, New Jersey, United States

Location

1220.48.0012 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

1220.48.0058 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Location

1220.48.0063 Boehringer Ingelheim Investigational Site

Arlington, Texas, United States

Location

1220.48.0029 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

1220.48.0017 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1220.48.0071 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1220.48.0081 Boehringer Ingelheim Investigational Site

Forth Worth, Texas, United States

Location

1220.48.4301 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1220.48.4302 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1220.48.3201 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1220.48.3204 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

1220.48.3203 Boehringer Ingelheim Investigational Site

Liège, Belgium

Location

1220.48.1012 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Location

1220.48.1003 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1220.48.1016 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1220.48.1007 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Location

1220.48.1009 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Location

1220.48.1005 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1220.48.1006 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1220.48.3301 Boehringer Ingelheim Investigational Site

Clichy, France

Location

1220.48.3311 Boehringer Ingelheim Investigational Site

Lille, France

Location

1220.48.3303 Boehringer Ingelheim Investigational Site

Marseille, France

Location

1220.48.3304 Boehringer Ingelheim Investigational Site

Montpellier, France

Location

1220.48.3305 Boehringer Ingelheim Investigational Site

Nice, France

Location

1220.48.3316 Boehringer Ingelheim Investigational Site

Pessac, France

Location

1220.48.3312 Boehringer Ingelheim Investigational Site

Saint-Laurent-du-Var, France

Location

1220.48.4902 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1220.48.4904 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1220.48.4913 Boehringer Ingelheim Investigational Site

Dortmund, Germany

Location

1220.48.4906 Boehringer Ingelheim Investigational Site

Düsseldorf, Germany

Location

1220.48.4901 Boehringer Ingelheim Investigational Site

Frankfurt am Main, Germany

Location

1220.48.4908 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1220.48.4914 Boehringer Ingelheim Investigational Site

Kiel, Germany

Location

1220.48.4911 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1220.48.4905 Boehringer Ingelheim Investigational Site

München, Germany

Location

1220.48.8106 Boehringer Ingelheim Investigational Site

Chiba, Chiba, Japan

Location

1220.48.8117 Boehringer Ingelheim Investigational Site

Kita-gun, Kagawa, Japan

Location

1220.48.8116 Boehringer Ingelheim Investigational Site

Kurashiki, Okayama, Japan

Location

1220.48.8118 Boehringer Ingelheim Investigational Site

Kurume, Fukuoka, Japan

Location

1220.48.8113 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1220.48.8114 Boehringer Ingelheim Investigational Site

Nishinomiya, Hyogo, Japan

Location

1220.48.8119 Boehringer Ingelheim Investigational Site

Omura, Nagasaki, Japan

Location

1220.48.8121 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1220.48.3503 Boehringer Ingelheim Investigational Site

Aveiro, Portugal

Location

1220.48.3509 Boehringer Ingelheim Investigational Site

Barreiro, Portugal

Location

1220.48.3501 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1220.48.3502 Boehringer Ingelheim Investigational Site

Porto, Portugal

Location

1220.48.4002 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1220.48.7001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1220.48.7004 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1220.48.8204 Boehringer Ingelheim Investigational Site

Pusan, South Korea

Location

1220.48.8205 Boehringer Ingelheim Investigational Site

Pusan, South Korea

Location

1220.48.8206 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1220.48.8207 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1220.48.8201 Boehringer Ingelheim Investigational Site

Yangsan, South Korea

Location

1220.48.3406 Boehringer Ingelheim Investigational Site

A Coruña, Spain

Location

1220.48.3402 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1220.48.3404 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1220.48.3411 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1220.48.3412 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1220.48.3405 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1220.48.3409 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1220.48.3410 Boehringer Ingelheim Investigational Site

Majadahonda-Madrid, Spain

Location

1220.48.3403 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

1220.48.3401 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1220.48.4106 Boehringer Ingelheim Investigational Site

Bern, Switzerland

Location

1220.48.8802 China Medical University Hospital

Taichung, Taiwan

Location

1220.48.4405 Boehringer Ingelheim Investigational Site

Bristol, United Kingdom

Location

1220.48.4409 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1220.48.4401 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

1220.48.4408 Boehringer Ingelheim Investigational Site

Nottingham, United Kingdom

Location

1220.48.4407 Boehringer Ingelheim Investigational Site

Oxford, United Kingdom

Location

1220.48.4403 Boehringer Ingelheim Investigational Site

Southampton, United Kingdom

Location

1220.48.4404 Boehringer Ingelheim Investigational Site

Tooting, London, United Kingdom

Location

Related Publications (1)

• Foster GR, Ferenci P, Asselah T, Mantry P, Dufour JF, Bourliere M, Forton D, Maevskaya M, Wright D, Yoshida EM, Garcia-Samaniego J, Oliveira C, Wright M, Warner N, Sha N, Quinson AM, Stern JO. Open-label study of faldaprevir plus peginterferon and ribavirin in hepatitis C virus genotype 1-infected patients who failed placebo plus peginterferon and ribavirin. J Viral Hepat. 2016 Mar;23(3):227-31. doi: 10.1111/jvh.12485. Epub 2015 Nov 17.

  PMID: 26572686 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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2011
• First Posted: April 6, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 30, 2016
• Results First Posted: July 31, 2015

Record last verified: 2016-05

Locations

GB (7); DE (9); RU (2); RO (1); US (20); FR (7); BE (3); TW (1); CA (7); CH (1); ES (10); AU (2); JP (8); PT (4); KR (5)