Hepatitis C VirusPhase 3PEDESTALNCT01598090

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

A Phase 3 study testing Peginterferon Lambda-1a, Peginterferon Alfa-2a and Ribavirin in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 104 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Hepatitis C Virus
What is being tested?: Peginterferon Lambda-1a, Peginterferon Alfa-2a and Ribavirin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 881 participants
Where: 104 sitesin 15 countries
Study dates: 14 Jun 2012to 15 May 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

104 sites in 15 countries.

Country

City, postcode or hospital

104 sites in 15 countries

United States28 sites

Anaheim Clinical Trials Llc
Anaheim, California, 92801
Metropolitan Research
Annandale, Virginia, 22003
Texas Clinical Research Institute
Arlington, Texas, 76012
Mercy Medical Center
Baltimore, Maryland, 21202
Birmingham Gastroenterology Associates, P.C.
Birmingham, Alabama, 35209
The Kirklin Clinic
Birmingham, Alabama, 35294
The University Of Alabama Of Birmingham
Birmingham, Alabama, 35294
Carolinas Medical Center
Charlotte, North Carolina, 28204
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Sc Clinical Research, Inc.
Garden Grove, California, 92844
Gastro One
Germantown, Tennessee, 38138
Saint Luke'S Transplant Specialists
Kansas City, Missouri, 64111
Va Long Beach Healthcare System
Long Beach, California, 90822
Cedars Sinai Medical Center
Los Angeles, California, 90048
Va Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Gastrointestinal Specialists Of Georgia Pc
Marietta, Georgia, 30060
Clinical Research Centers Of America
Murray, Utah, 84123
Bon Secours St. Mary'S Hospital Of Richmond, Inc.
Newport News, Virginia, 23602
Digestive And Liver Disease Specialists
Norfolk, Virginia, 23502
Orlando Va Medical Center
Orlando, Florida, 32803
Orlando Clinical Research Center
Orlando, Florida, 32809
Alamo Medical Research
San Antonio, Texas, 78215
University Of California, San Francisco/Sf General Hospital
San Francisco, California, 94110
Saint Louis University
St Louis, Missouri, 63104
Infectious Disease Research Institute, Inc.
Tampa, Florida, 33614
South Bay Ge Medical Group
Torrance, California, 90505
Options Health Research, Llc
Tulsa, Oklahoma, 74104
Healthcare Research Consultants
Tulsa, Oklahoma, 74135

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Brazil12 sites

Local Institution
Botucatu, São Paulo, 18618-000
Local Institution
Botucatu, São Paulo, 18618
Local Institution
Curitiba, Paraná, 80240-280
Local Institution
Curitiba, Paraná, 80240
Local Institution
Porto Alegre, Rio Grande do Sul, 90035-003
Local Institution
Porto Alegre, Rio Grande do Sul, 90035
Local Institution
Rio de Janeiro, 21040-000
Local Institution
Rio de Janeiro, 21040
Local Institution
Salvador, Estado de Bahia, 40110-160
Local Institution
Salvador, Estado de Bahia, 40110
Local Institution
São Paulo, 04035-970
Local Institution
São Paulo, 04035

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Russia11 sites

Local Institution
Kazan', Tatarstan Republic, 420012
Local Institution
Moscow, 105275
Local Institution
Moscow, 107996
Local Institution
Moscow, 111123
Local Institution
Moscow, 115446
Local Institution
Moscow, 117198
Local Institution
Moscow, 117593
Local Institution
Moscow, 127015
Local Institution
Saint Petersburg, 194100
Local Institution
Saint Petersburg, 198103
Local Institution
Stavropol, 355017

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Germany7 sites

Local Institution
Berlin, 10969
Local Institution
Essen, 45122
Local Institution
Frankfurt, 60590
Local Institution
Hamburg, 20246
Local Institution
Hanover, 30625
Local Institution
Münster, 48149
Local Institution
Ulm, 89081

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Canada6 sites

University Of Calgary
Calgary, Alberta, T2N 4Z6
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Toronto General Hospital
Toronto, Ontario, M5G 2N2
Liver And Intestinal Research Centre (Lair)
Vancouver, British Columbia, V5Z 1H2
Gastrointestinal Research Institute (G.I.R.I.)
Vancouver, British Columbia, V6Z 2K5
Percuro Clinical Research Ltd
Victoria, British Columbia, V8V 3P9

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France6 sites

Local Institution
Orléans, 45067
Local Institution
Poitiers, 86021
Local Institution
Rennes, 35033
Local Institution
Rouen, 76031
Local Institution
Toulouse, 31059
Local Institution
Villejuif, 94804

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Poland6 sites

Local Institution
Bialystok, 15-540
Local Institution
Kielce, 25-726
Local Institution
Łańcut, 37-100
Local Institution
Mysłowice, 41-400
Local Institution
Racibórz, 47-400
Local Institution
Wroclaw, 50-220

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Spain6 sites

Local Institution
A Coruña, 15006
Local Institution
Alicante, 03010
Local Institution
Donostia / San Sebastian, 20014
Local Institution
Santiago de Compostela, 15706
Local Institution
Seville, 41013
Local Institution
Seville, 41014

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Israel5 sites

Local Institution
Haifa, 31096
Local Institution
Haifa, 34362
Local Institution
Jerusalem, 91031
Local Institution
Nazareth, 16100
Local Institution
Ramat Gan, 52621

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Italy5 sites

Local Institution
Bergamo, 24127
Local Institution
Cisanello (pisa), 56124
Local Institution
Milan, 20121
Local Institution
Roma, 00149
Local Institution
Torino, 10126

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Belgium4 sites

Local Institution
Brussels, 1200
Local Institution
Edegem, 2650
Local Institution
Leuven, 3000
Local Institution
Liège, 4000

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Czechia3 sites

Local Institution
Hradec Králové, 500 05
Local Institution
Prague, 120 00
Local Institution
Prague, 140 21

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Austria2 sites

Local Institution
Graz, 8036
Local Institution
Linz, 4010

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Switzerland2 sites

Local Institution
Basel, 4031
Local Institution
Zurich, 8091

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United Kingdom1 site

Local Institution
Birmingham, WEST Midlands, B15 2TH

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About this study

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

Conditions: Hepatitis C Virus
Being tested: Peginterferon Lambda-1a, Peginterferon Alfa-2a, Ribavirin, Telaprevir
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Peginterferon Lambda-1aBiological
Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response
Peginterferon Alfa-2aBiological
Also called Pegasys
Syringes, SC, 180μg, Once weekly, 24 or 48 weeks depending on response
RibavirinDrug
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response
TelaprevirDrug
Also called Incivek
Tablets, Oral, 750 mg, three times a day, 12 weeks only

Study groups in NCT01598090
Study group	Role	What they receive
Part A: Peginterferon Lambda-1a + RBV + TVR	Experimental	Not described Receives: Biological: Peginterferon Lambda-1a; Drug: Ribavirin; Drug: Telaprevir
Part B (Arm 1): Peginterferon Lambda-1a + RBV + TVR	Experimental	Not described Receives: Biological: Peginterferon Lambda-1a; Drug: Ribavirin; Drug: Telaprevir
Part B (Arm 2): Peginterferon Lambda-2a + RBV + TVR	Experimental	Not described Receives: Biological: Peginterferon Alfa-2a; Drug: Ribavirin; Drug: Telaprevir

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A
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).
Measured: Assessed at Week 4 and Week 12, week 12 reported
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
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).
Measured: Follow-up Week 12
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A
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.
Measured: Day 1 of treatment up to Week 48

Secondary outcomes (8)

Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A
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).
Measured: Follow-up Week 12
Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A
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.
Measured: Follow up week 24
Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
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).
Measured: Follow-up Week 12
Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B
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.
Measured: After Day 1 of treatment up to Week 48
Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B
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).
Measured: Week 4 and Week 12
Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B
Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain.
Measured: After Day 1 of treatment up to Week 48
Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B
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).
Measured: Follow-up Week 24
Percentage of Participants With Rash
All skin reactions involving rash or rash-like events that occurred on treatment were reported.
Measured: After Day 1 of treatment up to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jun 201215 May 2015

First posted15 May 2012 (estimated)
Study start14 Jun 2012
Primary completion4 Feb 2015
Study completion15 May 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis C VirusStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 881 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01598090
Sponsor's protocol ID: AI452-020
Other IDs: 2011-004695-11
Acronym: PEDESTAL
Status last verified: Jul 2019
First submitted: 9 May 2012
Last updated: 31 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Heim MH. 25 years of interferon-based treatment of chronic hepatitis C: an epoch coming to an end. Nat Rev Immunol. 2013 Jul;13(7):535-42. doi: 10.1038/nri3463. Epub 2013 Jun 7.
PubMed 23743475

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01598090
Acronym / sponsor ID: PEDESTAL / AI452-020
Conditions: Hepatitis C Virus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 881 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 14 Jun 2012 (actual)
Primary completion: 4 Feb 2015 (actual)
Study completion: 15 May 2015 (actual)
First posted: 15 May 2012 (estimated)
Results: Posted 21 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Part A: Peginterferon Lambda-1a + RBV + TVR	Experimental	Biological: Peginterferon Lambda-1a, Drug: Ribavirin, Drug: Telaprevir
Part B (Arm 1): Peginterferon Lambda-1a + RBV + TVR	Experimental	Biological: Peginterferon Lambda-1a, Drug: Ribavirin, Drug: Telaprevir
Part B (Arm 2): Peginterferon Lambda-2a + RBV + TVR	Experimental	Biological: Peginterferon Alfa-2a, Drug: Ribavirin, Drug: Telaprevir

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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%

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Peginterferon Lambda-1aSyringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response	Biological	Part A: Peginterferon Lambda-1a + RBV + TVR, Part B (Arm 1): Peginterferon Lambda-1a + RBV + TVR
Peginterferon Alfa-2aAlso: PegasysSyringes, SC, 180μg, Once weekly, 24 or 48 weeks depending on response	Biological	Part B (Arm 2): Peginterferon Lambda-2a + RBV + TVR
RibavirinTablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response	Drug	Part A: Peginterferon Lambda-1a + RBV + TVR, Part B (Arm 1): Peginterferon Lambda-1a + RBV + TVR, Part B (Arm 2): Peginterferon Lambda-2a + RBV + TVR
TelaprevirAlso: IncivekTablets, Oral, 750 mg, three times a day, 12 weeks only	Drug	Part A: Peginterferon Lambda-1a + RBV + TVR, Part B (Arm 1): Peginterferon Lambda-1a + RBV + TVR, Part B (Arm 2): Peginterferon Lambda-2a + RBV + TVR

Primary outcome

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).
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).
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.

8 secondary outcomes

Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A
Time frame: Follow-up Week 12
Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A
Time frame: Follow up week 24
Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
Time frame: Follow-up Week 12
Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B
Time frame: After Day 1 of treatment up to Week 48
Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B
Time frame: Week 4 and Week 12
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
Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B
Time frame: Follow-up Week 24
Percentage of Participants With Rash
Time frame: After Day 1 of treatment up to Week 48

Results and safety

Results posted to the registry on 21 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)	27	16
Part B: Peginterferon Lambda-1a + RBV + TVR	411	339
Part B: Peginterferon Alfa-2a + RBV + TVR	206	171

Primary outcome: Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A

Time frame: Assessed at Week 4 and Week 12, week 12 reported. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) n = 27
Value	51.9 (31.9 to 71.3)

Population analysed: 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.

Primary outcome: Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B

Time frame: Follow-up Week 12. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Part B: Peginterferon Lambda-1a + RBV + TVR n = 411	Part B: Peginterferon Alfa-2a + RBV + TVR n = 206
Value	76.2 (72 to 80.3)	82 (76.8 to 87.3)

Part B: Peginterferon Lambda-1a + RBV + TVR vs Part B: Peginterferon Alfa-2a + RBV + TVR: p = 0.0855, Mantel Haenszel

Population analysed: 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.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) n = 27
AEs	26
SAEs	6
Drug related AEs	12
Discontinuation due to AEs	2
Death	0
Dose reductions - Lambda	3
Dose reductions - RBV	7

Population analysed: Safety analysis included all treated participants.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 of treatment up to Week 48. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)	6 of 27 (22.2%)	26 of 27 (96.3%)	0 of 27
Part B: Peginterferon Lambda-1a + RBV + TVR	43 of 411 (10.5%)	369 of 411 (89.8%)	1 of 411
Part B: Peginterferon Alfa-2a + RBV + TVR	20 of 206 (9.7%)	197 of 206 (95.6%)	1 of 206

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23743475Heim MH. 25 years of interferon-based treatment of chronic hepatitis C: an epoch coming to an end. Nat Rev Immunol. 2013 Jul;13(7):535-42. doi: 10.1038/nri3463. Epub 2013 Jun 7.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

104 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Peginterferon Lambda-1a, Peginterferon Alfa-2a and Ribavirin in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 104 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United States, Brazil, Russia, Germany, Canada and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A (time frame: Assessed at Week 4 and Week 12, week 12 reported). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01598090, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019; AzTrials last refreshed its copy on 31 Oct 2026.