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

Hepatitis C Virus Clinical Trial

— PEDESTAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598090
• Other study ID #: AI452-020
• Secondary ID: 2011-004695-11
• Status: Completed
• Phase: Phase 3
• Start date: June 14, 2012
• Est. completion date: May 15, 2015

Study information

• Verified date: July 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 881
• Est. completion date: May 15, 2015
• Est. primary completion date: February 4, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C Virus

Intervention

Biological:
• Peginterferon Lambda-1a
Syringes, subcutaneous (SC), 180µg, Once weekly, 24 or 48 weeks depending on response
• Peginterferon Alfa-2a
Syringes, 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
• Telaprevir
Tablets, Oral, 750 mg, three times a day, 12 weeks only

Locations

Country	Name	City	State
Austria	Local Institution	Graz
Austria	Local Institution	Linz
Belgium	Local Institution	Bruxelles
Belgium	Local Institution	Edegem
Belgium	Local Institution	Leuven
Belgium	Local Institution	Liege
Brazil	Local Institution	Botucatu	SAO Paulo
Brazil	Local Institution	Botucatu	Sao Paulo
Brazil	Local Institution	Curitiba	Parana
Brazil	Local Institution	Curitiba	Parana
Brazil	Local Institution	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution	Rio De Janeiro
Brazil	Local Institution	Rio De Janeiro
Brazil	Local Institution	Salvador	Bahia
Brazil	Local Institution	Salvador	Bahia
Brazil	Local Institution	Sao Paulo
Brazil	Local Institution	Sao Paulo
Canada	University Of Calgary	Calgary	Alberta
Canada	Hopital Maisonneuve-Rosemont	Montreal	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Gastrointestinal Research Institute (G.I.R.I.)	Vancouver	British Columbia
Canada	Liver And Intestinal Research Centre (Lair)	Vancouver	British Columbia
Canada	Percuro Clinical Research Ltd	Victoria	British Columbia
Czechia	Local Institution	Hradec Kralove
Czechia	Local Institution	Praha 2
Czechia	Local Institution	Praha 4
France	Local Institution	Orleans Cedex 2
France	Local Institution	Poitiers
France	Local Institution	Rennes Cedex 9
France	Local Institution	Rouen Cedex
France	Local Institution	Toulouse Cedex
France	Local Institution	Villejuif
Germany	Local Institution	Berlin
Germany	Local Institution	Essen
Germany	Local Institution	Frankfurt
Germany	Local Institution	Hamburg
Germany	Local Institution	Hannover
Germany	Local Institution	Muenster
Germany	Local Institution	Ulm
Israel	Local Institution	Haifa
Israel	Local Institution	Haifa
Israel	Local Institution	Jerusalem
Israel	Local Institution	Nazareth
Israel	Local Institution	Ramat Gan
Italy	Local Institution	Bergamo
Italy	Local Institution	Cisanello (pisa)
Italy	Local Institution	Milano
Italy	Local Institution	Roma
Italy	Local Institution	Torino
Poland	Local Institution	Bialystok
Poland	Local Institution	Kielce
Poland	Local Institution	Lancut
Poland	Local Institution	Myslowice
Poland	Local Institution	Raciborz
Poland	Local Institution	Wroclaw
Russian Federation	Local Institution	Kazan	Republic OF Tatarstan
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Saint Petersburg
Russian Federation	Local Institution	St-petersburg
Russian Federation	Local Institution	Stavropol
Spain	Local Institution	A Coruna
Spain	Local Institution	Alicante
Spain	Local Institution	San Sebastian
Spain	Local Institution	Santiago De Compostela
Spain	Local Institution	Sevilla
Spain	Local Institution	Sevilla
Switzerland	Local Institution	Basel
Switzerland	Local Institution	Zurich
United Kingdom	Local Institution	Birmingham	WEST Midlands
United States	Anaheim Clinical Trials Llc	Anaheim	California
United States	Metropolitan Research	Annandale	Virginia
United States	Texas Clinical Research Institute	Arlington	Texas
United States	Mercy Medical Center	Baltimore	Maryland
United States	Birmingham Gastroenterology Associates, P.C.	Birmingham	Alabama
United States	The Kirklin Clinic	Birmingham	Alabama
United States	The University Of Alabama Of Birmingham	Birmingham	Alabama
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Sc Clinical Research, Inc.	Garden Grove	California
United States	Gastro One	Germantown	Tennessee
United States	Saint Luke'S Transplant Specialists	Kansas City	Missouri
United States	Va Long Beach Healthcare System	Long Beach	California
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Va Greater Los Angeles Healthcare System	Los Angeles	California
United States	Gastrointestinal Specialists Of Georgia Pc	Marietta	Georgia
United States	Clinical Research Centers Of America	Murray	Utah
United States	Bon Secours St. Mary'S Hospital Of Richmond, Inc.	Newport News	Virginia
United States	Digestive And Liver Disease Specialists	Norfolk	Virginia
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Orlando Va Medical Center	Orlando	Florida
United States	Saint Louis University	Saint Louis	Missouri
United States	Alamo Medical Research	San Antonio	Texas
United States	University Of California, San Francisco/Sf General Hospital	San Francisco	California
United States	Infectious Disease Research Institute, Inc.	Tampa	Florida
United States	South Bay Ge Medical Group	Torrance	California
United States	Healthcare Research Consultants	Tulsa	Oklahoma
United States	Options Health Research, Llc	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Brazil,  Canada,  Czechia,  France,  Germany,  Israel,  Italy,  Poland,  Russian Federation,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Assessed at Week 4 and Week 12, week 12 reported
Primary	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).	Follow-up Week 12
Primary	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.	Day 1 of treatment up to Week 48
Secondary	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).	Follow-up Week 12
Secondary	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.	Follow up week 24
Secondary	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).	Follow-up Week 12
Secondary	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.	After Day 1 of treatment up to Week 48
Secondary	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).	Week 4 and Week 12
Secondary	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.	After Day 1 of treatment up to Week 48
Secondary	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).	Follow-up Week 24
Secondary	Percentage of Participants With Rash	All skin reactions involving rash or rash-like events that occurred on treatment were reported.	After Day 1 of treatment up to Week 48

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Patient Recruiting
•   Investigator Inquiry form