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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hepatitis C Virus
Interventions Biological: Peginterferon Lambda-1a
Biological: Peginterferon Alfa-2a
Drug: Ribavirin
Drug: Telaprevir
Enrollment 881
Recruitment Details  
Pre-assignment Details Out of 881 participants who were enrolled, 648 were randomized and only 644 were treated. 27 participants were treated in Part A and 617 participants were treated in Part B of the study.
Arm/Group Title Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
Hide Arm/Group Description Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
Period Title: Treatment Period
Started 27 411 206
Completed 16 339 171
Not Completed 11 72 35
Reason Not Completed
Poor/non-compliance             0             2             0
No longer meet study criteria             0             1             0
Lack of Efficacy             5             14             6
Adverse Event             2             33             17
Other reasons             0             4             1
Withdrawal by Subject             3             13             10
Lost to Follow-up             1             5             1
Period Title: Follow-up Period
Started 26 [1] 399 [2] 199 [3]
Completed 21 364 171
Not Completed 5 35 28
Reason Not Completed
Death             0             1             0
No longer required per protocol             1             3             2
Not reported             0             10             4
Withdrawal by Subject             0             3             2
Other reasons             2             8             8
Lost to Follow-up             2             10             12
[1]
Includes 10 participants who re-joined from treatment period to follow-up period.
[2]
Includes 60 participants who re-joined from treatment period to follow-up period.
[3]
Includes 28 participants who re-joined from treatment period to follow-up period.
Arm/Group Title Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR Total
Hide Arm/Group Description Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Total of all reporting groups
Overall Number of Baseline Participants 27 411 206 644
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 411 participants 206 participants 644 participants
<21 years
0
   0.0%
5
   1.2%
2
   1.0%
7
   1.1%
21 - <65 years
27
 100.0%
392
  95.4%
197
  95.6%
616
  95.7%
>=65 years
0
   0.0%
14
   3.4%
7
   3.4%
21
   3.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 411 participants 206 participants 644 participants
Female
9
  33.3%
152
  37.0%
80
  38.8%
241
  37.4%
Male
18
  66.7%
259
  63.0%
126
  61.2%
403
  62.6%
1.Primary Outcome
Title Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A
Hide Description 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).
Time Frame Assessed at Week 4 and Week 12, week 12 reported
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
Hide Arm/Group Description:
Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
Overall Number of Participants Analyzed 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
51.9
(31.9 to 71.3)
2.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
Hide Description 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).
Time Frame Follow-up Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
Hide Arm/Group Description:
Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
Overall Number of Participants Analyzed 411 206
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
76.2
(72 to 80.3)
82
(76.8 to 87.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B: Peginterferon Lambda-1a + RBV + TVR, Part B: Peginterferon Alfa-2a + RBV + TVR
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority of Lambda/RBV/TVR to Alfa/RBV/TVR was not established because the lower limit of the 95% CI was less than the predefined non-inferiority margin of -12%. As a result, key secondary endpoints were not tested hierarchically to compare treatment groups.
Statistical Test of Hypothesis P-Value 0.0855
Comments Non-inferiority testing is based on lower limit of confidence interval.
Method Mantel Haenszel
Comments [Not Specified]
3.Primary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A
Hide Description 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.
Time Frame Day 1 of treatment up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis included all treated participants.
Arm/Group Title Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
Hide Arm/Group Description:
Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
26
  96.3%
SAEs
6
  22.2%
Drug related AEs
12
  44.4%
Discontinuation due to AEs
2
   7.4%
Death
0
   0.0%
Dose reductions - Lambda
3
  11.1%
Dose reductions - RBV
7
  25.9%
4.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A
Hide Description 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).
Time Frame Follow-up Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
Hide Arm/Group Description:
Participants were followed up for 48 weeks who received treatment as: Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.
Overall Number of Participants Analyzed 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
48.1
(28.7 to 68.1)
5.Secondary Outcome
Title Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A
Hide Description 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.
Time Frame Follow up week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed using Observed value method, defined as proportions of participants meeting response criteria in numerator and denominator - all treated participants with HCV RNA measured at follow-up Week 24. Analysis was performed in all treated participants with HCV RNA measured at follow-up Week 24 due to early study termination.
Arm/Group Title Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
Hide Arm/Group Description:
Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
Overall Number of Participants Analyzed 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
40.7
(22.4 to 61.2)
6.Secondary Outcome
Title Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
Hide Description 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).
Time Frame Follow-up Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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 treatment-naive treated participants.
Arm/Group Title Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
Hide Arm/Group Description:
Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
Overall Number of Participants Analyzed 311 155
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
73.6
(68.7 to 78.5)
81.9
(75.9 to 88)
7.Secondary Outcome
Title Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B
Hide Description 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.
Time Frame After Day 1 of treatment up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
Hide Arm/Group Description:
Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
Overall Number of Participants Analyzed 411 206
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
11.7
(8.6 to 14.8)
55.8
(49 to 62.6)
8.Secondary Outcome
Title Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B
Hide Description 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).
Time Frame Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
Hide Arm/Group Description:
Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
Overall Number of Participants Analyzed 411 206
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
64
(59.3 to 68.6)
70.9
(64.7 to 77.1)
9.Secondary Outcome
Title Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B
Hide Description Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain.
Time Frame After Day 1 of treatment up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
Hide Arm/Group Description:
Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
Overall Number of Participants Analyzed 411 206
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Flu-Like Symptoms
14.4
(11 to 17.7)
36.4
(29.8 to 43)
Musculoskeletal symptoms
21.4
(17.4 to 25.4)
30.6
(24.3 to 36.9)
10.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B
Hide Description 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).
Time Frame Follow-up Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed using Observed value method, defined as proportions of participants meeting response criteria in numerator and denominator - all treated participants with HCV RNA measured at follow-up Week 24. Analysis was performed in all treated participants with HCV RNA measured at follow-up Week 24 due to early study termination.
Arm/Group Title Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
Hide Arm/Group Description:
Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
Overall Number of Participants Analyzed 223 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
83
(78 to 87.9)
87
(80.7 to 93.4)
11.Secondary Outcome
Title Percentage of Participants With Rash
Hide Description All skin reactions involving rash or rash-like events that occurred on treatment were reported.
Time Frame After Day 1 of treatment up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all treated participants.
Arm/Group Title Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
Hide Arm/Group Description:
Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
Overall Number of Participants Analyzed 27 411 206
Measure Type: Number
Unit of Measure: Percentage of participants
63 36.3 38.3
Time Frame Day 1 of treatment up to Week 48
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
Hide Arm/Group Description Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period.
All-Cause Mortality
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)      1/411 (0.24%)      1/206 (0.49%)    
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Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/27 (22.22%)      43/411 (10.46%)      20/206 (9.71%)    
Blood and lymphatic system disorders       
Anaemia  1  0/27 (0.00%)  0 1/411 (0.24%)  1 3/206 (1.46%)  4
Pancytopenia  1  0/27 (0.00%)  0 0/411 (0.00%)  0 1/206 (0.49%)  1
Cardiac disorders       
Atrial fibrillation  1  0/27 (0.00%)  0 1/411 (0.24%)  1 0/206 (0.00%)  0
Myocardial infarction  1  0/27 (0.00%)  0 0/411 (0.00%)  0 1/206 (0.49%)  1
Endocrine disorders       
Hyperthyroidism  1  0/27 (0.00%)  0 1/411 (0.24%)  1 0/206 (0.00%)  0
Eye disorders       
Ocular icterus  1  0/27 (0.00%)  0 3/411 (0.73%)  3 0/206 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  1/27 (3.70%)  1 0/411 (0.00%)  0 0/206 (0.00%)  0
Peptic ulcer haemorrhage  1  1/27 (3.70%)  1 0/411 (0.00%)  0 0/206 (0.00%)  0
Pancreatitis acute  1  0/27 (0.00%)  0 2/411 (0.49%)  2 1/206 (0.49%)  1
Ileus  1  0/27 (0.00%)  0 1/411 (0.24%)  1 0/206 (0.00%)  0
Nausea  1  0/27 (0.00%)  0 1/411 (0.24%)  1 0/206 (0.00%)  0
Vomiting  1  0/27 (0.00%)  0 1/411 (0.24%)  1 0/206 (0.00%)  0
Colitis  1  0/27 (0.00%)  0 0/411 (0.00%)  0 1/206 (0.49%)  1
Diarrhoea  1  0/27 (0.00%)  0 0/411 (0.00%)  0 1/206 (0.49%)  1
Gastrointestinal vascular malformation  1  0/27 (0.00%)  0 0/411 (0.00%)  0 1/206 (0.49%)  1
General disorders       
Strangulated hernia  1  0/27 (0.00%)  0 1/411 (0.24%)  1 0/206 (0.00%)  0
Hepatobiliary disorders       
Jaundice  1  3/27 (11.11%)  3 11/411 (2.68%)  11 2/206 (0.97%)  2
Drug-induced liver injury  1  0/27 (0.00%)  0 4/411 (0.97%)  4 0/206 (0.00%)  0
Hepatotoxicity  1  0/27 (0.00%)  0 2/411 (0.49%)  2 0/206 (0.00%)  0
Hypertransaminasaemia  1  0/27 (0.00%)  0 2/411 (0.49%)  2 0/206 (0.00%)  0
Jaundice cholestatic  1  0/27 (0.00%)  0 2/411 (0.49%)  2 0/206 (0.00%)  0
Hyperbilirubinaemia  1  0/27 (0.00%)  0 1/411 (0.24%)  1 0/206 (0.00%)  0
Infections and infestations       
Pneumonia  1  0/27 (0.00%)  0 1/411 (0.24%)  1 0/206 (0.00%)  0
Injury, poisoning and procedural complications       
Overdose  1  1/27 (3.70%)  1 1/411 (0.24%)  1 0/206 (0.00%)  0
Investigations       
Alanine aminotransferase increased  1  0/27 (0.00%)  0 1/411 (0.24%)  1 0/206 (0.00%)  0
Aspartate aminotransferase increased  1  0/27 (0.00%)  0 1/411 (0.24%)  1 0/206 (0.00%)  0
Blood creatinine increased  1  0/27 (0.00%)  0 1/411 (0.24%)  1 0/206 (0.00%)  0
Electrocardiogram QT prolonged  1  0/27 (0.00%)  0 1/411 (0.24%)  1 0/206 (0.00%)  0
Hepatic enzyme increased  1  0/27 (0.00%)  0 1/411 (0.24%)  1 0/206 (0.00%)  0
Lipase increased  1  0/27 (0.00%)  0 1/411 (0.24%)  1 0/206 (0.00%)  0
Pancreatic enzymes increased  1  0/27 (0.00%)  0 1/411 (0.24%)  1 0/206 (0.00%)  0
Carotid bruit  1  0/27 (0.00%)  0 0/411 (0.00%)  0 1/206 (0.49%)  1
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/27 (0.00%)  0 1/411 (0.24%)  1 0/206 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma  1  0/27 (0.00%)  0 1/411 (0.24%)  1 0/206 (0.00%)  0
Nervous system disorders       
Syncope  1  0/27 (0.00%)  0 1/411 (0.24%)  1 1/206 (0.49%)  1
Demyelination  1  0/27 (0.00%)  0 0/411 (0.00%)  0 1/206 (0.49%)  1
Psychiatric disorders       
Substance-induced psychotic disorder  1  0/27 (0.00%)  0 0/411 (0.00%)  0 1/206 (0.49%)  1
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  0/27 (0.00%)  0 0/411 (0.00%)  0 2/206 (0.97%)  2
Hypoxia  1  0/27 (0.00%)  0 0/411 (0.00%)  0 1/206 (0.49%)  1
Skin and subcutaneous tissue disorders       
Rash  1  0/27 (0.00%)  0 1/411 (0.24%)  1 5/206 (2.43%)  5
Drug reaction with eosinophilia and systemic symptoms  1  0/27 (0.00%)  0 0/411 (0.00%)  0 1/206 (0.49%)  1
1
Term from vocabulary, MedDRA version 17.1
Indicates events were collected by systematic assessment
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Frequency Threshold for Reporting Other Adverse Events 5%
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/27 (96.30%)      369/411 (89.78%)      197/206 (95.63%)    
Blood and lymphatic system disorders       
Anaemia  1  3/27 (11.11%)  3 53/411 (12.90%)  55 100/206 (48.54%)  111
Neutropenia  1  0/27 (0.00%)  0 10/411 (2.43%)  17 35/206 (16.99%)  45
Leukopenia  1  0/27 (0.00%)  0 9/411 (2.19%)  13 32/206 (15.53%)  41
Thrombocytopenia  1  0/27 (0.00%)  0 1/411 (0.24%)  2 17/206 (8.25%)  22
Gastrointestinal disorders       
Nausea  1  11/27 (40.74%)  12 172/411 (41.85%)  195 67/206 (32.52%)  78
Diarrhoea  1  13/27 (48.15%)  13 61/411 (14.84%)  70 37/206 (17.96%)  43
Vomiting  1  5/27 (18.52%)  5 66/411 (16.06%)  93 25/206 (12.14%)  29
Anal pruritus  1  4/27 (14.81%)  4 59/411 (14.36%)  64 22/206 (10.68%)  22
Anorectal discomfort  1  5/27 (18.52%)  5 28/411 (6.81%)  30 17/206 (8.25%)  18
Dyspepsia  1  2/27 (7.41%)  2 28/411 (6.81%)  30 13/206 (6.31%)  17
Haemorrhoids  1  1/27 (3.70%)  1 17/411 (4.14%)  17 11/206 (5.34%)  11
Proctalgia  1  2/27 (7.41%)  2 8/411 (1.95%)  9 5/206 (2.43%)  6
General disorders       
Fatigue  1  16/27 (59.26%)  16 143/411 (34.79%)  162 75/206 (36.41%)  92
Asthenia  1  0/27 (0.00%)  0 81/411 (19.71%)  95 61/206 (29.61%)  69
Pyrexia  1  2/27 (7.41%)  2 31/411 (7.54%)  37 53/206 (25.73%)  61
Influenza like illness  1  3/27 (11.11%)  4 26/411 (6.33%)  29 36/206 (17.48%)  39
Chills  1  1/27 (3.70%)  1 35/411 (8.52%)  42 35/206 (16.99%)  41
Injection site reaction  1  4/27 (14.81%)  4 7/411 (1.70%)  7 6/206 (2.91%)  6
Pain  1  2/27 (7.41%)  2 6/411 (1.46%)  6 6/206 (2.91%)  6
Oedema peripheral  1  2/27 (7.41%)  2 15/411 (3.65%)  16 3/206 (1.46%)  3
Injection site rash  1  3/27 (11.11%)  3 6/411 (1.46%)  6 0/206 (0.00%)  0
Hepatobiliary disorders       
Hyperbilirubinaemia  1  3/27 (11.11%)  3 44/411 (10.71%)  56 4/206 (1.94%)  4
Infections and infestations       
Upper respiratory tract infection  1  2/27 (7.41%)  2 3/411 (0.73%)  4 4/206 (1.94%)  4
Gastroenteritis  1  2/27 (7.41%)  2 5/411 (1.22%)  5 2/206 (0.97%)  2
Investigations       
Amylase increased  1  0/27 (0.00%)  0 21/411 (5.11%)  26 3/206 (1.46%)  5
Blood bilirubin increased  1  2/27 (7.41%)  3 19/411 (4.62%)  25 2/206 (0.97%)  2
Alanine aminotransferase increased  1  2/27 (7.41%)  2 30/411 (7.30%)  33 1/206 (0.49%)  2
Aspartate aminotransferase increased  1  1/27 (3.70%)  1 30/411 (7.30%)  38 1/206 (0.49%)  2
Bilirubin conjugated increased  1  2/27 (7.41%)  2 6/411 (1.46%)  9 1/206 (0.49%)  1
Metabolism and nutrition disorders       
Decreased appetite  1  1/27 (3.70%)  1 85/411 (20.68%)  93 42/206 (20.39%)  47
Hyperuricaemia  1  1/27 (3.70%)  1 32/411 (7.79%)  43 11/206 (5.34%)  11
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/27 (3.70%)  1 49/411 (11.92%)  58 43/206 (20.87%)  55
Myalgia  1  4/27 (14.81%)  4 49/411 (11.92%)  61 43/206 (20.87%)  56
Muscle spasms  1  4/27 (14.81%)  4 14/411 (3.41%)  14 2/206 (0.97%)  2
Nervous system disorders       
Headache  1  8/27 (29.63%)  9 66/411 (16.06%)  76 42/206 (20.39%)  54
Dizziness  1  2/27 (7.41%)  2 52/411 (12.65%)  55 24/206 (11.65%)  33
Dysgeusia  1  3/27 (11.11%)  3 11/411 (2.68%)  11 9/206 (4.37%)  11
Syncope  1  2/27 (7.41%)  2 5/411 (1.22%)  5 1/206 (0.49%)  1
Psychiatric disorders       
Insomnia  1  8/27 (29.63%)  8 102/411 (24.82%)  110 56/206 (27.18%)  63
Anxiety  1  0/27 (0.00%)  0 13/411 (3.16%)  14 11/206 (5.34%)  11
Depression  1  5/27 (18.52%)  6 25/411 (6.08%)  26 11/206 (5.34%)  11
Irritability  1  3/27 (11.11%)  3 33/411 (8.03%)  40 8/206 (3.88%)  8
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  2/27 (7.41%)  2 31/411 (7.54%)  34 37/206 (17.96%)  41
Cough  1  3/27 (11.11%)  3 12/411 (2.92%)  13 24/206 (11.65%)  27
Skin and subcutaneous tissue disorders       
Pruritus  1  13/27 (48.15%)  13 187/411 (45.50%)  209 100/206 (48.54%)  126
Rash  1  12/27 (44.44%)  13 123/411 (29.93%)  131 57/206 (27.67%)  62
Dry skin  1  1/27 (3.70%)  1 52/411 (12.65%)  56 27/206 (13.11%)  27
Alopecia  1  1/27 (3.70%)  1 9/411 (2.19%)  9 23/206 (11.17%)  24
Rash generalised  1  5/27 (18.52%)  5 4/411 (0.97%)  4 2/206 (0.97%)  2
Skin exfoliation  1  2/27 (7.41%)  2 4/411 (0.97%)  4 2/206 (0.97%)  2
1
Term from vocabulary, MedDRA version 17.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
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Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: clinical.trials@bms.com
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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 Submitted: May 9, 2012
First Posted: May 15, 2012
Results First Submitted: March 21, 2019
Results First Posted: May 21, 2019
Last Update Posted: July 31, 2019