Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)

NCT00984620 | Completed Phase 2 Results

• 2 other identifiers: 1220.402009-012579-90
• Study Type: interventional
• Target: 160
• Locations: 6 countries
• Sites: 28

Brief Summary

To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Virological Response at Week 28 (W28VR)

  Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28.

  28 weeks

Secondary Outcomes (15)

• Rapid Virological Response at Week 4 (RVR)

  4 weeks

• Virological Response at Week 24 (W24VR)

  24 weeks

• Virological Response at Week 36 (W36VR)

  36 weeks

• End of Treatment Response (ETR)

  up to 48 weeks

• Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy

  72 weeks

Study Arms (2)

short arm

EXPERIMENTAL

patients to receive BI201335 with PegIFN/RBV for 12 wks followed by 12 weeks PegIFN/RBV with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV)

Drug: BI 201335; Drug: Pegylated Interferon-alpha (IFN); Drug: Ribavirin (RBV)

long arm

EXPERIMENTAL

patients to receive BI201335 with PegIFN/RBV for 24 wks with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV)

Drug: BI 201335; Drug: Pegylated Interferon-alpha (IFN); Drug: Ribavirin (RBV)

Interventions

BI 201335 DRUG

BI 201335

long arm

Pegylated Interferon-alpha (IFN) DRUG

Pegylated Interferon-alpha

long arm; short arm

Ribavirin (RBV) DRUG

Ribavirin (RBV)

long arm; short arm

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 genotype 1
• Therapy-naïve to interferon, pegylated interferon, and ribavirin
• HCV viral load \> 100.000 IU/ml at screening
• Liver biopsy or fibroscan within two years prior to screening that provides evidence of any degree of fibrosis or cirrhosis
• Normal retinal finding on fundoscopy within 6 months prior to Day 1
• Age 18 to 70 years

You may not qualify if:

• HCV of mixed genotype (1/2, 1/3, and 1/4) .
• Patients who have been previously treated with at least one dose of any protease inhibitor
• Evidence of liver disease due to causes other than chronic HCV infection
• Positive for HIV-1 or HIV-2 antibodies
• Hepatitis B virus (HBV) infection
• Decompensated liver disease, or history of decompensated liver disease
• Active malignancy or history of malignancy within the last 5 years
• History of alcohol or drug abuse (except cannabis) within the past 12 months.
• Body Mass Index \< 18 or \> 35 kg/m2.
• Usage of any investigational drugs within 30 days prior to enrolment
• Alpha fetoprotein value \>100ng/mL at screening;
• Total bilirubin \> 1.5 x ULN with ratio of direct/indirect \> 1.
• ALT or AST level \> 10 x ULN

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (28)

1220.40.002 Boehringer Ingelheim Investigational Site

Tulepo, Mississippi, United States

Location

1220.40.007 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

1220.40.006 Boehringer Ingelheim Investigational Site

Germantown, Tennessee, United States

Location

1220.40.004 Boehringer Ingelheim Investigational Site

Jackson, Tennessee, United States

Location

1220.40.003 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

Location

1220.40.005 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

1220.40.4303 Boehringer Ingelheim Investigational Site

Linz, Austria

Location

1220.40.4301 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1220.40.1004 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Location

1220.40.1001 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1220.40.1002 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

1220.40.1003 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1220.40.1005 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1220.40.3303A Boehringer Ingelheim Investigational Site

Clichy, France

Location

1220.40.3305A Boehringer Ingelheim Investigational Site

Lille, France

Location

1220.40.3301A Boehringer Ingelheim Investigational Site

Marseille, France

Location

1220.40.3306A Boehringer Ingelheim Investigational Site

Montpellier, France

Location

1220.40.3302A Boehringer Ingelheim Investigational Site

Paris, France

Location

1220.40.3304A Boehringer Ingelheim Investigational Site

Rennes, France

Location

1220.40.4902 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1220.40.4909 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1220.40.4906 Boehringer Ingelheim Investigational Site

Düsseldorf, Germany

Location

1220.40.4908 Boehringer Ingelheim Investigational Site

Düsseldorf, Germany

Location

1220.40.4904 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1220.40.4905 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1220.40.4001 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1220.40.4002 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1220.40.4003 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

Related Publications (1)

• Dieterich D, Asselah T, Guyader D, Berg T, Schuchmann M, Mauss S, Ratziu V, Ferenci P, Larrey D, Maieron A, Stern JO, Ozan M, Datsenko Y, Bocher WO, Steinmann G. SILEN-C3, a phase 2 randomized trial with faldaprevir plus pegylated interferon alpha-2a and ribavirin in treatment-naive hepatitis C virus genotype 1-infected patients. Antimicrob Agents Chemother. 2014 Jun;58(6):3429-36. doi: 10.1128/AAC.02497-13. Epub 2014 Apr 7.

  PMID: 24709256 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

faldaprevir; Ribavirin

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

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

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 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 25, 2009
• Study Start: September 1, 2009
• Primary Completion: April 1, 2011
• Last Updated: September 7, 2015
• Results First Posted: September 7, 2015

Record last verified: 2015-08

Locations

US (6); AU (2); CA (5); FR (6); RO (3); DE (6)