Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)

NCT00774397 | Completed Phase 2 Results

• 2 other identifiers: 1220.52008-003538-11
• Study Type: interventional
• Target: 719
• Locations: 14 countries
• Sites: 97

Brief Summary

The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated interferon α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed in treatment-naïve (TN) and treatment experienced (TE) patients.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (2)

• Virological Response 4 Weeks After the End of Treatment With BI 201335 or Placebo

  An achieved virological response is defined as the plasma Hepatitis C Virus RiboNucleic Acid (HCV RNA) level below the lower limit of detection (BLD). This data was only collected for patients, who stopped trial participation at Week 24 and did not continue with PegIFN/RBV until Week 48. The lower limit of quantification (BLQ) of this assay was 25 IU/mL and the lower limit of detection (BLD) was 10 IU/mL at the time of the protocol finalisation. During the course of the trial, the manufacturer defined BLD as '\< 25 IU/mL, not detectable' and BLQ as '\< 25 IU/mL, detectable'.

  Week 28

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

  Virological (VL) response was defined as the plasma HCV RNA level below the lower limit of detection. The first VL measurement that occurred in the time window ≥ Day 155 (from End Of Treatment on) was selected for the determination of SVR24. Therefore, patients with virological load BLD 24 weeks after completion of therapy, who had a rebound after this time point (outside the defined time window of 155 days after end of all treatments) were identified as SVR24 achieved.

  Day 155 after the end of all treatment

Secondary Outcomes (30)

• Virological Response at Week 2

  Week 2

• Virological Response at Week 4

  Week 4

• Early Virological Response (EVR)

  Baseline and Week 12

• Extended Rapid Virological Response (eRVR)

  Week 4 and Week 12

• Complete Early Virological Response (cEVR)

  Week 12

Study Arms (7)

240 mg QD TN

EXPERIMENTAL

240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

Drug: BI 201335 NA 240 mg QD; Drug: PegIFN/RBV

240 mg QD / LI-TN

EXPERIMENTAL

240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 (Faldaprevir) three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

Drug: BI 201335 NA 240 mg QD / LI; Drug: PegIFN/RBV

Placebo

PLACEBO COMPARATOR

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

Drug: PegIFN/RBV; Drug: Placebo

120 mg QD / LI-TN

EXPERIMENTAL

120 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 (Faldaprevir) three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

Drug: BI 201335 NA 120mg QD / LI; Drug: PegIFN/RBV

240 mg QD TE

EXPERIMENTAL

240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

Drug: BI 201335 NA 240 mg QD; Drug: PegIFN/RBV

240 mg QD / LI-TE

EXPERIMENTAL

240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 (Faldaprevir) three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

Drug: PegIFN/RBV; Drug: BI 201335 NA 240 mg QD

240 mg BID / LI-TE

EXPERIMENTAL

240mg BI 201335 NA (Faldaprevir) twice daily combined with PegIFN/RBV for 24 or 48 weeks, with 3-day lead-in phase of PegIFN/RBV, in treatment-experienced patients

Drug: BI 201335 NA 240 mg BID; Drug: PegIFN/RBV

Interventions

BI 201335 NA 240 mg QD / LI DRUG

240mg BI 201335 NA (Faldaprevir) once daily with a 3 days lead-in phase of PegIFN/RB, 24 weeks

Also known as: Faldaprevir

240 mg QD / LI-TN

PegIFN/RBV DRUG

PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks

240 mg QD / LI-TN

BI 201335 NA 120mg QD / LI DRUG

120mg BI 201335 NA (Faldaprevir) once daily, for 24 weeks

Also known as: Faldaprevir

120 mg QD / LI-TN

BI 201335 NA 240 mg QD DRUG

240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks

Also known as: Faldaprevir

240 mg QD TN

BI 201335 NA 240 mg BID DRUG

240mg BI 201335 NA (Faldaprevir) twice, 24 weeks

Also known as: Faldaprevir

240 mg BID / LI-TE

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• chronic HCV GT1; therapy-naive to IFN, PegIFN, or RBV; HCV VL \>=100,000 IU/mL Liver biopsy within 2 years prior to study enrolment showing necroinflammatory activity or presence of fibrosis Normal retinal finding on fundoscopy within 6 months prior to Day 1 age 18-65 years Females and males with adequate contraception

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (100)

1220.5.0001 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Location

1220.5.0008 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Location

1220.5.0005 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1220.5.0006 Boehringer Ingelheim Investigational Site

Lutherville, Maryland, United States

Location

1220.5.0002 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

1220.5.0003 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

1220.5.0007 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

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1220.5.0010 Boehringer Ingelheim Investigational Site

Germantown, Tennessee, United States

Location

1220.5.0009 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

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1220.5.0004 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

1220.5.5401 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1220.5.5403 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1220.5.5405 Boehringer Ingelheim Investigational Site

Derqui, Pilar, Argentina

Location

1220.5.5402 Boehringer Ingelheim Investigational Site

Rosario, Argentina

Location

1220.5.5406 Boehringer Ingelheim Investigational Site

Rosario, Argentina

Location

1220.5.6110 Boehringer Ingelheim Investigational Site

Camperdown, New South Wales, Australia

Location

1220.5.6109 Boehringer Ingelheim Investigational Site

Kogarah, New South Wales, Australia

Location

1220.5.6105 Boehringer Ingelheim Investigational Site

Randwick, New South Wales, Australia

Location

1220.5.6101 Boehringer Ingelheim Investigational Site

Westmead, New South Wales, Australia

Location

1220.5.6103 Boehringer Ingelheim Investigational Site

Herston, Queensland, Australia

Location

1220.5.6104 Boehringer Ingelheim Investigational Site

Woolloongabba, Queensland, Australia

Location

1220.5.6102 Boehringer Ingelheim Investigational Site

Clayton, Victoria, Australia

Location

1220.5.6107 Boehringer Ingelheim Investigational Site

Fitzroy, Victoria, Australia

Location

1220.5.6108 Boehringer Ingelheim Investigational Site

Parkville, Victoria, Australia

Location

1220.5.4303 Boehringer Ingelheim Investigational Site

Linz, Austria

Location

1220.5.4301 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1220.5.4302 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1220.5.1003 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Location

1220.5.1007 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

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1220.5.1006 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1220.5.1001 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

1220.5.1002 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1220.5.1004 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1220.5.4202 Boehringer Ingelheim Investigational Site

Mělník, Czechia

Location

1220.5.4203 Boehringer Ingelheim Investigational Site

Opava, Czechia

Location

1220.5.3301A Boehringer Ingelheim Investigational Site

Clichy, France

Location

1220.5.3307A Boehringer Ingelheim Investigational Site

Créteil, France

Location

1220.5.3309A Boehringer Ingelheim Investigational Site

Lyon, France

Location

1220.5.3304A Boehringer Ingelheim Investigational Site

Marseille, France

Location

1220.5.3306A Boehringer Ingelheim Investigational Site

Montpellier, France

Location

1220.5.3302A Boehringer Ingelheim Investigational Site

Paris, France

Location

1220.5.3303A Boehringer Ingelheim Investigational Site

Paris, France

Location

1220.5.3308A Boehringer Ingelheim Investigational Site

Paris, France

Location

1220.5.3305A Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, France

Location

1220.5.4902 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1220.5.4903 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1220.5.4917 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1220.5.4914 Boehringer Ingelheim Investigational Site

Bochum, Germany

Location

1220.5.4913 Boehringer Ingelheim Investigational Site

Bonn, Germany

Location

1220.5.4915 Boehringer Ingelheim Investigational Site

Dortmund, Germany

Location

1220.5.4905 Boehringer Ingelheim Investigational Site

Düsseldorf, Germany

Location

1220.5.4912 Boehringer Ingelheim Investigational Site

Düsseldorf, Germany

Location

1220.5.4906 Boehringer Ingelheim Investigational Site

Frankfurt am Main, Germany

Location

1220.5.4908 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1220.5.4904 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

1220.5.4910 Boehringer Ingelheim Investigational Site

Leipzig, Germany

Location

1220.5.4909 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1220.5.4907 Boehringer Ingelheim Investigational Site

Tübingen, Germany

Location

1220.5.3101 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

1220.5.3102 Boehringer Ingelheim Investigational Site

Leiden, Netherlands

Location

1220.5.3501 Boehringer Ingelheim Investigational Site

Coimbra, Portugal

Location

1220.5.3504 Boehringer Ingelheim Investigational Site

Coimbra, Portugal

Location

1220.5.3502 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1220.5.3503 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1220.5.3506 Boehringer Ingelheim Investigational Site

Porto, Portugal

Location

1220.5.3507 Boehringer Ingelheim Investigational Site

Porto, Portugal

Location

1220.5.4001 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1220.5.4002 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1220.5.4003 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1220.5.4004 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1220.5.8210 Boehringer Ingelheim Investigational Site

Busan, South Korea

Location

1220.5.8205 Boehringer Ingelheim Investigational Site

Daegu, South Korea

Location

1220.5.8201 Boehringer Ingelheim Investigational Site

Pusan, South Korea

Location

1220.5.8202 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1220.5.8206 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1220.5.8207 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1220.5.8208 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1220.5.8204 Boehringer Ingelheim Investigational Site

Seoungnam, South Korea

Location

1220.5.8203 Boehringer Ingelheim Investigational Site

Sungnam, South Korea

Location

1220.5.8209 Boehringer Ingelheim Investigational Site

Suwon, South Korea

Location

1220.5.8211 Boehringer Ingelheim Investigational Site

Yangsan, South Korea

Location

1220.5.3402 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1220.5.3405 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1220.5.3401 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1220.5.3403 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1220.5.3404 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1220.5.3406 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1220.5.4104 Boehringer Ingelheim Investigational Site

Bern, Switzerland

Location

1220.5.4102 Boehringer Ingelheim Investigational Site

La Chaux-de-Fonds, Switzerland

Location

1220.5.4103 Boehringer Ingelheim Investigational Site

Lugano, Switzerland

Location

1220.5.4101 Boehringer Ingelheim Investigational Site

Zurich, Switzerland

Location

1220.5.4106 Boehringer Ingelheim Investigational Site

Zurich, Switzerland

Location

1220.5.4405 Boehringer Ingelheim Investigational Site

Bristol, United Kingdom

Location

1220.5.4401 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1220.5.4402 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1220.5.4406 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1220.5.4409 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1220.5.4410 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1220.5.4408 Boehringer Ingelheim Investigational Site

Nottingham, United Kingdom

Location

1220.5.4403 Boehringer Ingelheim Investigational Site

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

faldaprevir; BID protein, human

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

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: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 17, 2008
• Study Start: October 1, 2008
• Primary Completion: November 1, 2011
• Last Updated: November 16, 2015
• Results First Posted: November 16, 2015

Record last verified: 2015-10

Locations

FR (9); US (10); AU (9); AR (5); CZ (2); DE (14); CH (5); RO (4); GB (8); NL (2); KR (11); CA (6); PT (6); ES (6)