A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
- Conditions
- Hepatitis C Virus (HCV)
- Interventions
- Drug: Glecaprevir/Pibrentasvir
- Registration Number
- NCT03089944
- Lead Sponsor
- AbbVie
- Brief Summary
A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 343
- Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1-6 infection.
- Positive plasma HCV antibody and HCV RNA viral load greater than or equal to 1000 IU/mL at Screening.
- Treatment-naive to any approved or investigational anti-HCV medication.
- Participant must be documented as cirrhotic, with a Child-Pugh score of less than or equal to 6.
- Female participant who is pregnant, breastfeeding or is considering becoming pregnant during the study, or for approximately 30 days after the last dose of study drug.
- Any current or historical clinical evidence of decompensated cirrhosis.
- Positive test result at Screening for hepatitis B surface antigen (HBsAg), HBV deoxyribonucleic acid > lower limit of quantification (LLOQ) in subjects with isolated positive antibody to hepatitis B core antigen (anti-HBc) (i.e., negative HBsAg and anti-hepatitis B),or anti human immunodeficiency virus antibody (HIV Ab).
- HCV genotype performed by the central laboratory during screening indicating co-infection with more than one HCV genotype.
- History of suspected or confirmed hepatocellular carcinoma.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks Glecaprevir/Pibrentasvir Glecaprevir (GLE)/Pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Hepatitis C Virus (HCV) Genotype (GT) 1,2,4,5 and 6-infected Participants in the Per Protocol (PP) Population 12 weeks after last dose of study drug SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (\<LLOQ; less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the percentage of participants with HCV GT1, GT2, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 94% in the PP population. Efficacy analyses were performed following a fixed-sequence testing procedure to control the type I error rate. The percentage of participants achieving SVR12 was summarized with a 2-sided 95% CI, calculated using the normal approximation to the binomial distribution. If the number of participants who failed to achieve SVR12 rate was less than 5, the Wilson's score method was used to calculate the CI.
Percentage of Participants With SVR12 in HCV GT 1,2,4,5 and 6-infected Participants in the Intent-To-Treat (ITT) Population 12 weeks after last dose of study drug SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants with HCV GT1, GT2, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 93% in the ITT population. Primary efficacy analyses were performed following a fixed-sequence testing procedure to control the type I error rate. The percentage of participants achieving SVR12 was summarized with a 2-sided 95% CI, calculated using the normal approximation to the binomial distribution. If the number of participants who failed to achieve SVR12 rate was less than 5, the Wilson's score method was used to calculate the CI.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With On-treatment Virologic Failure in the ITT Population 8 weeks on treatment On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU/mL after HCV RNA \< LLOQ during treatment; confirmed increase of \> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the PP Population 12 weeks after the last dose of study drug SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug.
Percentage of Participants With Post-treatment Relapse Up to 12 weeks after the last dose of study drug Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned (defined as study drug duration ≥ 52 days for participants assigned to 8 weeks of treatment) and with HCV RNA levels \< LLOQ at the end of treatment excluding participants who had been reinfected.
Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the PP Population 12 weeks after last dose of study drug SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants with HCV GT1, GT2, GT3, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 94% in the PP population. These efficacy analyses were performed only if success was demonstrated for both primary efficacy analyses, following a fixed-sequence testing procedure.
Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the ITT Population 12 weeks after the last dose of study drug SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants with HCV GT1, GT2, GT3, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 93% in the ITT population. These efficacy analyses were performed only if success was demonstrated for both primary efficacy analyses, following a fixed-sequence testing procedure.
Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the ITT Population 12 weeks after the last dose of study drug SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug.
Trial Locations
- Locations (113)
Piedmont Hospital /ID# 162646
🇺🇸Atlanta, Georgia, United States
General Hospital of Athens Laiko /ID# 162786
🇬🇷Athens, Attiki, Greece
Bioclinic Thessaloniki /ID# 162785
🇬🇷Thessaloniki, Greece
GHGCPR Research Institute /ID# 162608
🇵🇷Ponce, Puerto Rico
Central Clinical Hospital of R /ID# 163434
🇷🇺Moscow, Russian Federation
Hospital Parc de Salut del Mar /ID# 162198
🇪🇸Barcelona, Spain
Hospital Donostia /ID# 162197
🇪🇸Donostia, Spain
Texas Digestive Disease Consul /ID# 162648
🇺🇸Dallas, Texas, United States
Percuro Clinical Research, Ltd /ID# 161184
🇨🇦Victoria, British Columbia, Canada
Usc /Id# 162248
🇺🇸Los Angeles, California, United States
Carolinas Center for Liver Dis /ID# 162569
🇺🇸Statesville, North Carolina, United States
Toronto General Hospital /ID# 161182
🇨🇦Toronto, Ontario, Canada
Universita della Campania Luigi Vanvitelli /ID# 162337
🇮🇹Napoli, Campania, Italy
Kaiser Permanente - San Diego (Palm Ave) /ID# 162289
🇺🇸San Diego, California, United States
University of Miami /ID# 162210
🇺🇸Miami, Florida, United States
Duke University Medical Center /ID# 162299
🇺🇸Durham, North Carolina, United States
Vanderbilt Univ Med Ctr /ID# 162211
🇺🇸Nashville, Tennessee, United States
Basildon University Hospital /ID# 162616
🇬🇧Basildon, Essex, United Kingdom
St. James's Hospital /ID# 162619
🇮🇪Dublin 8, Dublin, Ireland
A.O.U. Policlinico S.Orsola-Malpighi /ID# 162335
🇮🇹Bologna, Emilia-Romagna, Italy
St. Josephs Hosp and Med Ctr /ID# 162762
🇺🇸Phoenix, Arizona, United States
Mayo Clinic Arizona /ID# 162314
🇺🇸Phoenix, Arizona, United States
Mayo Clinic - Rochester /ID# 162251
🇺🇸Rochester, Minnesota, United States
CHI Health Alegent Creighton /ID# 162286
🇺🇸Omaha, Nebraska, United States
Univ Nebraska Med Ctr /ID# 162285
🇺🇸Omaha, Nebraska, United States
Liver Wellness Center /ID# 162244
🇺🇸Little Rock, Arkansas, United States
Felizarta /ID# 162295
🇺🇸Bakersfield, California, United States
VA Long Beach Healthcare System /ID# 162298
🇺🇸Long Beach, California, United States
Cedars-Sinai Medical Center - West Hollywood /ID# 162313
🇺🇸West Hollywood, California, United States
Stanford University School of Med /ID# 162209
🇺🇸Stanford, California, United States
Triple O Research Institute /ID# 162300
🇺🇸West Palm Beach, Florida, United States
Northwestern University Feinberg School of Medicine /ID# 162208
🇺🇸Chicago, Illinois, United States
Unity Point Health /ID# 162247
🇺🇸Des Moines, Iowa, United States
The University of Iowa Hospita /ID# 162214
🇺🇸Iowa City, Iowa, United States
Southern Therapy and Advanced Research (STAR) LLC /ID# 162241
🇺🇸Jackson, Mississippi, United States
Montefiore Medical Center /ID# 162312
🇺🇸Bronx, New York, United States
Rnjms /Id# 162213
🇺🇸Newark, New Jersey, United States
Weill Cornell Medical College /ID# 161051
🇺🇸New York, New York, United States
James J. Peters VA Medical Center /ID# 162644
🇺🇸Bronx, New York, United States
Cumberland Research Assoc /ID# 162212
🇺🇸Fayetteville, North Carolina, United States
Icahn School of Med Mt. Sinai /ID# 162294
🇺🇸New York, New York, United States
University Hospitals Cleveland /ID# 162243
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic /ID# 162570
🇺🇸Cleveland, Ohio, United States
Osuchs /Id# 162284
🇺🇸Tulsa, Oklahoma, United States
Lehigh Valley Health Network /ID# 162603
🇺🇸Allentown, Pennsylvania, United States
Center for Liver Diseases, Oakland /ID# 162568
🇺🇸Pittsburgh, Pennsylvania, United States
Univ of Wisconsin Hosp/Clinics /ID# 162645
🇺🇸Madison, Wisconsin, United States
University of Texas Health /ID# 162288
🇺🇸Houston, Texas, United States
Tokuda Hospital Sofia /ID# 163422
🇧🇬Sofia, Bulgaria
DCC Fokus-5 - LZIP /ID# 163338
🇧🇬Sofia, Bulgaria
Univ Hosp for Active Treat /ID# 163330
🇧🇬Sofia, Bulgaria
UMHAT Sv. Ivan Rilski /ID# 163332
🇧🇬Sofia, Bulgaria
University of Calgary /ID# 161185
🇨🇦Calgary, Alberta, Canada
Qe Ii Hsc /Id# 161178
🇨🇦Halifax, Nova Scotia, Canada
The Ottawa Hospital Research /ID# 161179
🇨🇦Ottawa, Ontario, Canada
Research Site s.r.o /ID# 163020
🇨🇿Plzen, Czechia
Institut Klinicke a Experimeth /ID# 162900
🇨🇿Prague, Czechia
KlinMed s.r.o. /ID# 162893
🇨🇿Prague, Czechia
CHR Orleans - Hopital de la Source /ID# 163072
🇫🇷Orleans CEDEX 2, Centre-Val De Loire, France
CHU Amiens Picardie /ID# 163071
🇫🇷Amiens CEDEX 1, Somme, France
CHU Estaing /ID# 163058
🇫🇷Clermont Ferrand, France
Hospital Henri Mondor /ID# 163061
🇫🇷Creteil, France
Hopital de la Croix Rousse /ID# 163073
🇫🇷Lyon, France
General and Oncology Hospital /ID# 162784
🇬🇷Kifissia, Greece
Reg Gen Univ Hosp Larissa /ID# 162783
🇬🇷Larisa, Greece
Szent Janos Korhaz /ID# 166542
🇭🇺Budapest, Hungary
Budai Hepatologiai Centrum /ID# 166511
🇭🇺Budapest, Hungary
St Vincent's Hospital /ID# 162617
🇮🇪Dublin 4, Ireland
Beaumont Hospital /ID# 162618
🇮🇪Dublin, Ireland
Tel Aviv Sourasky Medical Ctr /ID# 162185
🇮🇱Tel Aviv-Yafo, Tel-Aviv, Israel
Rambam Health Care Campus /ID# 162023
🇮🇱Haifa, Israel
The Lady Davis Carmel MC /ID# 162017
🇮🇱Haifa, Israel
Sheba Medical Center /ID# 162028
🇮🇱Ramat Gan, Israel
ASST Grande Ospedale Metropolitano Niguarda /ID# 162340
🇮🇹Milano, Lombardia, Italy
Istituto Clinico Humanitas /ID# 162336
🇮🇹Rozzano, Milano, Italy
Polo Universitario Luigi Sacco /ID# 162339
🇮🇹Milan, Italy
Centrum Badan Klinicznych, Przychodnia Badan Klinicznych /ID# 162760
🇵🇱Wrocław, Dolnoslaskie, Poland
HepID - Diagnostyka I Terapia /ID# 162761
🇵🇱Lublin, Lubelskie, Poland
Uniwersytecki Szpital Kliniczn /ID# 162757
🇵🇱Bialystok, Poland
ID Clinic /ID# 162759
🇵🇱Myslowice, Poland
Centro Hosp de Lisboa Central /ID# 163770
🇵🇹Lisbon, Lisboa, Portugal
Centro Hospitalar Lisboa Norte, EPE /ID# 163785
🇵🇹Lisboa, Portugal
Centro Hospitalar do Porto EPE /ID# 163765
🇵🇹Porto, Portugal
Centro Hospitalar de Sao Joao /ID# 163766
🇵🇹Porto, Portugal
Instituto de Investigacion Cientifica del Sur /ID# 162566
🇵🇷Ponce, Puerto Rico
Klinical Investigations Group /ID# 162565
🇵🇷San Juan, Puerto Rico
Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 163484
🇷🇴Sector 2, Bucuresti, Romania
Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 164449
🇷🇴Sector 2, Bucuresti, Romania
Institutul Clinic Fundeni /ID# 163479
🇷🇴Sector 2, Bucuresti, Romania
Institutul Clinic Fundeni /ID# 163500
🇷🇴Sector 2, Bucuresti, Romania
Stavropol State Medical Univ /ID# 161999
🇷🇺Stavropol, Russian Federation
RSAHI Consulting and Diagnostic Centre /ID# 161995
🇷🇺Tyumen, Russian Federation
CBSI Central scientific and research institute of epidemiology /ID# 161996
🇷🇺Moscow, Russian Federation
LLC Medical Company Hepatolog /ID# 161998
🇷🇺Samara, Samarskaya Oblast, Russian Federation
Hospital Univ Vall d'Hebron /ID# 162199
🇪🇸Barcelona, Spain
Hospital Universitario Reina S /ID# 162200
🇪🇸Cordoba, Spain
China Medical University Hosp /ID# 162950
🇨🇳Taichung City, Taichung, Taiwan
Hospital Univ Central Asturias /ID# 162195
🇪🇸Oviedo, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 162949
🇨🇳Kaohsiung, Taiwan
Taipei Veterans General Hosp /ID# 162776
🇨🇳Taipei City, Taiwan
The Royal Free Hospital /ID# 162614
🇬🇧London, London, City Of, United Kingdom
Western General Hospital /ID# 162612
🇬🇧Edinburgh, United Kingdom
North Manchester General /ID# 163945
🇬🇧Crumpsall, United Kingdom
Queens Medical Centre /ID# 162615
🇬🇧Nottinghamshire, United Kingdom
National Hospital of Tropical Diseases /ID# 167974
🇻🇳Hanoi, Vietnam
Hoa Hao Medic Co. Ltd. /ID# 168178
🇻🇳Ho Chi Minh, Vietnam
Tropical Diseases Hospital /ID# 168211
🇻🇳Ho Chi Minh, Vietnam
Louisiana Research Ctr. LLC /ID# 162567
🇺🇸Shreveport, Louisiana, United States
Mercy Medical Center /ID# 162291
🇺🇸Baltimore, Maryland, United States
Institutul Nat. de Boli Infectioase /ID# 163488
🇷🇴Bucuresti, Romania
Hôpital Purpan /ID# 163065
🇫🇷TOULOUSE Cedex 9, Haute-Garonne, France
University of Louisville /ID# 162242
🇺🇸Louisville, Kentucky, United States
Virginia Commonwealth Univ /ID# 162215
🇺🇸Richmond, Virginia, United States