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Trial record 1 of 3 for:    HCVerso
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IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01732796
First received: November 6, 2012
Last updated: November 5, 2014
Last verified: November 2014
  Purpose

The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Ribavirin (RBV)
Drug: BI 201335 (Faldaprevir)
Drug: BI 207127
Drug: Faldaprevir (BI 201335)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 HCV Infection

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Sustained Virologic Response at Week 12 after end of active treatment (SVR 12) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sustained Virologic Response at Week 4 after end of active treatment (SVR4) [ Time Frame: 4 weeks after end of active treatment ] [ Designated as safety issue: No ]
  • Sustained Virologic Response at Week 24 after end of active treatment (SVR24) [ Time Frame: 24 weeks after end of active treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 475
Study Start Date: December 2012
Estimated Study Completion Date: January 2015
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allocated 24 weeks BI 207127 + BI 201335
24 weeks of BI 207127 and BI 201335 in combination with Ribavirin
Drug: Ribavirin (RBV)
24 weeks of active RBV
Drug: BI 201335 (Faldaprevir)
24 weeks of BI 201335
Drug: BI 207127
24 weeks of BI 207127
Experimental: Randomized 16 weeks BI 7127+BI1335 + RBV
16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV
Drug: BI 201335 (Faldaprevir)
16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335
Drug: Ribavirin (RBV)
16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin
Drug: BI 207127
16 weeks BI 207127 followed by 8 weeks placebo to BI 207127
Experimental: Randomized 24weeks BI 7127+ BI1335 + RBV
24 weeks of BI 207127and BI 201335 in combination with RBV
Drug: Ribavirin (RBV)
24 weeks of active RBV
Drug: BI 207127
24 weeks of BI 207127
Drug: Faldaprevir (BI 201335)
24 weeks of 201335

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Chronic hepatitis C infection, diagnosed by positive HCV Ab or detectable HCV RNA at screening in addition to at least one of the following:

    1. positive HCV RNA or HCV antibodies at least 6 months prior to screening, or
    2. liver biopsy typical of chronic hepatitis C , or
    3. history of elevated ALT at least 6 months prior to screening.
  • HCV infection of sub-GT1b confirmed by genotypic testing at screening
  • Treatment naïve defined as:

    1. no prior treatment with any interferon, pegylated interferon, and /or ribavirin and
    2. no prior treatment with at least one dose of any other licensed or investigational antiviral agent for acute or chronic hepatitis C infection
  • Plasma HCV RNA > or = 1,000 IU/mL at screening
  • Liver biopsy within three years or fibroscan within six months prior to randomization. Patients with compensated liver cirrhosis (score Child-Pugh A) could also be included.
  • Age 18 to 75 years
  • Female patients with a negative urine pregnancy test (dipstick) at Visit 2 prior to randomization

    1. with documented hysterectomy, or
    2. who have had both ovaries removed, or
    3. with documented tubal ligation, or
    4. who are post-menopausal with last menstrual period at least 12 months prior to screening, or
    5. of childbearing potential with a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 (Visit 2), that agree to use two non-hormonal methods of birth control from the date of screening until months after the last dose of ribavirin. They must not breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin. Medically accepted methods of contraception for females in this trial are diaphragm with spermicide substance, intrauterine devices, cervical caps and condoms.

OR:

Male patients

  1. who are documented to be sterile, or
  2. who consistently and correctly use a condom while their female partners (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, and
  3. without pregnant female partners. It is in the responsibility of the male patient to ensure that his partner (or partners) is not pregnant prior to enrolment into the study or becomes pregnant during the treatment and follow-up 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).

Exclusion criteria:

  • HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
  • HCV subtype 1a, mixed 1a/1b or GT1 undefined
  • Evidence of liver disease mainly due to causes other than chronic HCV infection such as autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson's disease
  • HIV-1 or HIV-2 infection
  • Hepatitis B virus (HBV) infection based on presence of HBs-Ag
  • Evidence of decompensated liver disease, or history of decompensated liver disease, defined as history of ascites, hepatic encephalopathy, or bleeding esophageal varices,
  • International Normalized Ratio (INR) > or =1.7
  • Serum albumin < 3.3 g/dL
  • Serum total bilirubin >2.0 times the upper limit of normal (ULN) with direct/indirect ratio >1, unless history of Gilbert's disease
  • Active or suspected malignancy or history of malignancy within the last 5 years (with the exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
  • Patients with ongoing or historical photosensitivity or recurrent rash
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732796

  Show 101 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01732796     History of Changes
Other Study ID Numbers: 1241.20, 2012-003533-41
Study First Received: November 6, 2012
Last Updated: November 5, 2014
Health Authority: Austria: Medicines and Medical Devices Agency
Canada: Health Canada
France: Agence Nationale sécurité médicament et des produits santé
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: Ethics Committee
Netherlands: Central Committee Research Involving Human Subjects
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Digestive System Diseases
Flaviviridae Infections
Hepatitis
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014