IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1

NCT01732796 | Completed Phase 3 Results

• 2 other identifiers: 1241.202012-003533-41
• Study Type: interventional
• Target: 470
• Locations: 14 countries
• Sites: 101

Brief Summary

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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (2)

• SVR12 Rates With Historical Control

  Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C Virus ribonucleic acid (HCV RNA) level \<25 international units/millilitre (IU/mL) at 12 weeks after End of Treatment (EoT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint

  12 Week (post-treatment)

• Comparisons of SVR12 Rates Across Treatment Arms

  Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.

  12 Week (post-treatment)

Secondary Outcomes (2)

• SVR4

  4 Week (post-treatment)

• SVR24

  24 Week (post-treatment)

Study Arms (3)

Allocated 24 weeks BI 207127 + BI 201335

EXPERIMENTAL

24 weeks of BI 207127 and BI 201335 in combination with Ribavirin

Drug: Ribavirin (RBV); Drug: BI 201335 (Faldaprevir); Drug: BI 207127

Randomized 16 weeks BI 7127+BI1335 + RBV

EXPERIMENTAL

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); Drug: Ribavirin (RBV); Drug: BI 207127

Randomized 24weeks BI 7127+ BI1335 + RBV

EXPERIMENTAL

24 weeks of BI 207127and BI 201335 in combination with RBV

Drug: Ribavirin (RBV); Drug: BI 207127; Drug: Faldaprevir (BI 201335)

Interventions

Ribavirin (RBV) DRUG

24 weeks of active RBV

Allocated 24 weeks BI 207127 + BI 201335

BI 201335 (Faldaprevir) DRUG

16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335

Randomized 16 weeks BI 7127+BI1335 + RBV

BI 207127 DRUG

24 weeks of BI 207127

Randomized 24weeks BI 7127+ BI1335 + RBV

Faldaprevir (BI 201335) DRUG

24 weeks of 201335

Randomized 24weeks BI 7127+ BI1335 + RBV

Eligibility Criteria

• Age: 18 Years - 75 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 HCV Ab or detectable HCV RNA at screening in addition to at least one of the following:
• positive HCV RNA or HCV antibodies at least 6 months prior to screening, or
• liver biopsy typical of chronic hepatitis C , or
• 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:
• no prior treatment with any interferon, pegylated interferon, and /or ribavirin and
• 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
• with documented hysterectomy, or
• who have had both ovaries removed, or
• with documented tubal ligation, or

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (101)

1241.20.00026 Boehringer Ingelheim Investigational Site

Dothan, Alabama, United States

Location

1241.20.00033 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

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1241.20.00006 Boehringer Ingelheim Investigational Site

La Mesa, California, United States

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1241.20.00003 Boehringer Ingelheim Investigational Site

Oceanside, California, United States

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1241.20.00008 Boehringer Ingelheim Investigational Site

Poway, California, United States

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1241.20.00015 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

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1241.20.00014 Boehringer Ingelheim Investigational Site

Ft. Pierce, Florida, United States

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1241.20.00004 Boehringer Ingelheim Investigational Site

Maitland, Florida, United States

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1241.20.00010 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

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1241.20.00001 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

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1241.20.00018 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

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1241.20.00002 Boehringer Ingelheim Investigational Site

Chevy Chase, Maryland, United States

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1241.20.00032 Boehringer Ingelheim Investigational Site

Springfield, Massachusetts, United States

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1241.20.00009 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

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1241.20.00016 Boehringer Ingelheim Investigational Site

New York, New York, United States

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1241.20.00031 Boehringer Ingelheim Investigational Site

New York, New York, United States

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1241.20.00019 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

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1241.20.00024 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

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1241.20.00013 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

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1241.20.00005 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

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1241.20.00017 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

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1241.20.00012 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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1241.20.00022 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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1241.20.00020 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

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1241.20.43003 Boehringer Ingelheim Investigational Site

Graz, Austria

Location

1241.20.01001 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

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1241.20.01008 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

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1241.20.01010 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

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1241.20.01003 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

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1241.20.01006 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

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1241.20.01002 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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1241.20.01005 Boehringer Ingelheim Investigational Site

Whitby, Ontario, Canada

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1241.20.01007 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1241.20.33003 Boehringer Ingelheim Investigational Site

Clermont-Ferrand, France

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1241.20.33004 Boehringer Ingelheim Investigational Site

Lyon, France

Location

1241.20.33006 Boehringer Ingelheim Investigational Site

Marseille, France

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1241.20.33001 Boehringer Ingelheim Investigational Site

Montpellier, France

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1241.20.33005 Boehringer Ingelheim Investigational Site

Nice, France

Location

1241.20.33007 Boehringer Ingelheim Investigational Site

Paris, France

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1241.20.33002 Boehringer Ingelheim Investigational Site

Pessac, France

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1241.20.33009 Boehringer Ingelheim Investigational Site

Rennes, France

Location

1241.20.33008 Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, France

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1241.20.49002 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1241.20.49004 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1241.20.49012 Boehringer Ingelheim Investigational Site

Bonn, Germany

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1241.20.49013 Boehringer Ingelheim Investigational Site

Cologne, Germany

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1241.20.49001 Boehringer Ingelheim Investigational Site

Frankfurt am Main, Germany

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1241.20.49014 Boehringer Ingelheim Investigational Site

Hamburg, Germany

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1241.20.49009 Boehringer Ingelheim Investigational Site

Herne, Germany

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1241.20.49008 Boehringer Ingelheim Investigational Site

Kiel, Germany

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1241.20.49011 Boehringer Ingelheim Investigational Site

Leipzig, Germany

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1241.20.49006 Boehringer Ingelheim Investigational Site

Magdeburg, Germany

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1241.20.49003 Boehringer Ingelheim Investigational Site

München, Germany

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1241.20.49010 Boehringer Ingelheim Investigational Site

Oberhausen, Germany

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1241.20.49005 Boehringer Ingelheim Investigational Site

Ulm, Germany

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1241.20.49007 Boehringer Ingelheim Investigational Site

Würzburg, Germany

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1241.20.36001 Boehringer Ingelheim Investigational Site

Budapest, Hungary

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1241.20.36002 Boehringer Ingelheim Investigational Site

Kaposvár, Hungary

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1241.20.35301 Boehringer Ingelheim Investigational Site

Dublin, Ireland

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1241.20.35302 Boehringer Ingelheim Investigational Site

Dublin, Ireland

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1241.20.35303 Boehringer Ingelheim Investigational Site

Dublin, Ireland

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1241.20.39007 Boehringer Ingelheim Investigational Site

Ancona, Italy

Location

1241.20.39003 Boehringer Ingelheim Investigational Site

Brescia, Italy

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1241.20.39002 Boehringer Ingelheim Investigational Site

Milan, Italy

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1241.20.39008 Boehringer Ingelheim Investigational Site

Milan, Italy

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1241.20.39006 Boehringer Ingelheim Investigational Site

Napoli, Italy

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1241.20.39005 Boehringer Ingelheim Investigational Site

Pavia, Italy

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1241.20.39001 Boehringer Ingelheim Investigational Site

Torino, Italy

Location

1241.20.39004 Boehringer Ingelheim Investigational Site

Torino, Italy

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1241.20.31001 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

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1241.20.31003 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

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1241.20.31004 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

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1241.20.31005 Boehringer Ingelheim Investigational Site

Groningen, Netherlands

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1241.20.31006 Boehringer Ingelheim Investigational Site

The Hague, Netherlands

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1241.20.35103 Boehringer Ingelheim Investigational Site

Aveiro, Portugal

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1241.20.35104 Boehringer Ingelheim Investigational Site

Coimbra, Portugal

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1241.20.35101 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

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1241.20.35102 Boehringer Ingelheim Investigational Site

Porto, Portugal

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1241.20.35105 Boehringer Ingelheim Investigational Site

Vila Real, Portugal

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1241.20.40001 Boehringer Ingelheim Investigational Site

Bucharest, Romania

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1241.20.40002 Boehringer Ingelheim Investigational Site

Bucharest, Romania

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1241.20.40003 Boehringer Ingelheim Investigational Site

Bucharest, Romania

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1241.20.70002 Boehringer Ingelheim Investigational Site

Chelyabinsk, Russia

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1241.20.70001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1241.20.70004 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1241.20.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

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1241.20.34007 Boehringer Ingelheim Investigational Site

A Coruña, Spain

Location

1241.20.34004 Boehringer Ingelheim Investigational Site

Alicante, Spain

Location

1241.20.34002 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1241.20.34005 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1241.20.34003 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1241.20.34001 Boehringer Ingelheim Investigational Site

Majadahonda, Madrid, Spain

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1241.20.34008 Boehringer Ingelheim Investigational Site

Santander, Spain

Location

1241.20.34006 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1241.20.44005 Boehringer Ingelheim Investigational Site

Bristol, United Kingdom

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1241.20.44007 Boehringer Ingelheim Investigational Site

Liverpool, United Kingdom

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1241.20.44001 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1241.20.44002 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1241.20.44006 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1241.20.44004 Boehringer Ingelheim Investigational Site

Nottingham, United Kingdom

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1241.20.44003 Boehringer Ingelheim Investigational Site

Southampton, United Kingdom

Location

Related Publications (1)

• Sarrazin C, Castelli F, Andreone P, Buti M, Colombo M, Pol S, Calinas F, Puoti M, Olveira A, Shiffman M, Stern JO, Kukolj G, Roehrle M, Aslanyan S, Deng Q, Vinisko R, Mensa FJ, Nelson DR. HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naive patients with chronic hepatitis C virus genotype-1b infection. Clin Exp Gastroenterol. 2016 Nov 24;9:351-363. doi: 10.2147/CEG.S111116. eCollection 2016.

  PMID: 27920566 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin; faldaprevir; deleobuvir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

BI stopped the further development of DBV, per protocol amendment the Follow-up period was reduced to 24 weeks for patients who achieved SVR12, and to 48 weeks for SVR12 non-responders provided they had not started an alternative HCV treatment.

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: November 6, 2012
• First Posted: November 26, 2012
• Study Start: December 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 18, 2016
• Results First Posted: April 18, 2016

Record last verified: 2016-03

Locations

CA (8); DE (14); HU (2); GB (7); ES (8); NL (5); FR (9); IE (3); PT (5); RO (3); AU (1); US (24); IT (8); RU (4)