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Trial record 27 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

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

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ClinicalTrials.gov Identifier: NCT01598090
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : May 21, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Biological: Peginterferon Lambda-1a Biological: Peginterferon Alfa-2a Drug: Ribavirin Drug: Telaprevir Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 881 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 14, 2012
Actual Primary Completion Date : February 4, 2015
Actual Study Completion Date : May 15, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part A: Peginterferon Lambda-1a + RBV + TVR Biological: Peginterferon Lambda-1a
Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response

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

Drug: Telaprevir
Tablets, Oral, 750 mg, three times a day, 12 weeks only
Other Name: Incivek

Experimental: Part B (Arm 1): Peginterferon Lambda-1a + RBV + TVR Biological: Peginterferon Lambda-1a
Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response

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

Drug: Telaprevir
Tablets, Oral, 750 mg, three times a day, 12 weeks only
Other Name: Incivek

Experimental: Part B (Arm 2): Peginterferon Lambda-2a + RBV + TVR Biological: Peginterferon Alfa-2a
Syringes, SC, 180μg, Once weekly, 24 or 48 weeks depending on response
Other Name: Pegasys

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

Drug: Telaprevir
Tablets, Oral, 750 mg, three times a day, 12 weeks only
Other Name: Incivek




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598090


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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01598090     History of Changes
Other Study ID Numbers: AI452-020
2011-004695-11 ( EudraCT Number )
First Posted: May 15, 2012    Key Record Dates
Results First Posted: May 21, 2019
Last Update Posted: July 31, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Peginterferon alfa-2a
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
Ribavirin
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs