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Completed

NCT Number: NCT01598090

Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir

The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.

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Key information

Conditions

Hepatitis C Virus Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion criteria

  • Chronic hepatitis C genotype 1. GT-1b Capped at 50 % of naïve subjects
  • Naives to prior anti-HCV therapy [Interferon (IFN) and direct antiviral agent (DAA) based]
  • Relapsers (defined as subjects who had undetectable HCV ribonucleic acid (RNA) on prior treatment regimen of alfa-2a/RBV and Hepatitis C Virus (HCV) RNA > 25IU/mL after discontinuation of treatment). Capped at 20%
  • HCV RNA ≥ 100,000 IU/mL
  • Subjects with compensated cirrhosis can be enrolled and will be capped at approximately 10%
  • Seronegative for human immunodeficiency virus (HIV) and hepatitis B surface antigen (HBsAg)
  • Men or women, 18-70 years of age

Exclusion criteria

  • Chronic liver disease due to causes other than chronic HCV
  • Current or past evidence of decompensation
  • Conditions that preclude the use of Alfa/RBV/TVR per respective labels
  • Diagnosed or suspected hepatocellular carcinoma

Treatment and study plan

Peginterferon Lambda-1a

Biological

Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response

peginterferon alfa-2a

Biological

Syringes, SC, 180μg, Once weekly, 24 or 48 weeks depending on response

Other names: Pegasys

Ribavirin

Drug

Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response

Telaprevir

Drug

Tablets, Oral, 750 mg, three times a day, 12 weeks only

Other names: Incivek

Primary outcomes

  1. Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A

    Time frame: Assessed at Week 4 and Week 12, week 12 reported

    eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).

  2. Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B

    Time frame: Follow-up Week 12

    SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).

  3. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A

    Time frame: Day 1 of treatment up to Week 48

    An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal product. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or caused prolongation of existing hospitalization.

Secondary outcomes

  1. Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A

    Time frame: Follow-up Week 12

    SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ =25 IU/mL; limit of detection ~ 10 IU/mL).

  2. Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A

    Time frame: Follow up week 24

    SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.

  3. Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B

    Time frame: Follow-up Week 12

    SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).

  4. Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B

    Time frame: After Day 1 of treatment up to Week 48

    Cytopenic abnormalities included anemia defined as hemoglobin <10 grams/decilitre; neutropenia defined as Absolute neutrophil count (ANC) <750 cubic millimetre (mm^3); thrombocytopenia defined as platelets <50,000 mm^3.

  5. Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B

    Time frame: Week 4 and Week 12

    eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).

  6. Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B

    Time frame: After Day 1 of treatment up to Week 48

    Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain.

  7. Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B

    Time frame: Follow-up Week 24

    SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL).

  8. Percentage of Participants With Rash

    Time frame: After Day 1 of treatment up to Week 48

    All skin reactions involving rash or rash-like events that occurred on treatment were reported.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 3 Blinded Randomized Study of Peginterferon Lambda-1a and Ribavirin Compared to Peginterferon Alfa-2a and Ribavirin, Each Administered With Telaprevir in Subjects With Genotype-1 Chronic Hepatitis C Who Are Treatment-naive or Relapsed on Prior Treatment With Peginterferon Alfa-2a and Ribavirin

Acronym: PEDESTAL

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 15, 2012
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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