Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis (EXPEDITION-8)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03089944
Recruitment Status : Completed
First Posted : March 24, 2017
Results First Posted : July 13, 2020
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus (HCV) Drug: Glecaprevir/Pibrentasvir Phase 3

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 343 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
Actual Study Start Date : April 28, 2017
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : November 8, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks
Glecaprevir (GLE)/Pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks.
Drug: Glecaprevir/Pibrentasvir
Tablet
Other Names:
  • ABT-493
  • ABT-530




Primary Outcome Measures :
  1. 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 [ Time Frame: 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.

  2. Percentage of Participants With SVR12 in HCV GT 1,2,4,5 and 6-infected Participants in the Intent-To-Treat (ITT) Population [ Time Frame: 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 :
  1. Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the PP Population [ Time Frame: 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.

  2. Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the ITT Population [ Time Frame: 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.

  3. Percentage of Participants With On-treatment Virologic Failure in the ITT Population [ Time Frame: 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.

  4. Percentage of Participants With Post-treatment Relapse [ Time Frame: 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.

  5. Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the PP Population [ Time Frame: 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.

  6. Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the ITT Population [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089944


Locations
Hide Hide 113 study locations
Layout table for location information
United States, Arizona
St. Josephs Hosp and Med Ctr /ID# 162762
Phoenix, Arizona, United States, 85013
Mayo Clinic Arizona /ID# 162314
Phoenix, Arizona, United States, 85054
United States, Arkansas
Liver Wellness Center /ID# 162244
Little Rock, Arkansas, United States, 72204
United States, California
Felizarta /ID# 162295
Bakersfield, California, United States, 93301
VA Long Beach Healthcare System /ID# 162298
Long Beach, California, United States, 90822
Usc /Id# 162248
Los Angeles, California, United States, 90033
Kaiser Permanente - San Diego (Palm Ave) /ID# 162289
San Diego, California, United States, 92154
Stanford University School of Med /ID# 162209
Stanford, California, United States, 94305-2200
Cedars-Sinai Medical Center - West Hollywood /ID# 162313
West Hollywood, California, United States, 90048
United States, Florida
University of Miami /ID# 162210
Miami, Florida, United States, 33136
Triple O Research Institute /ID# 162300
West Palm Beach, Florida, United States, 33407-3100
United States, Georgia
Piedmont Hospital /ID# 162646
Atlanta, Georgia, United States, 30309
United States, Illinois
Northwestern University Feinberg School of Medicine /ID# 162208
Chicago, Illinois, United States, 60611-2927
United States, Iowa
Unity Point Health /ID# 162247
Des Moines, Iowa, United States, 50309
The University of Iowa Hospita /ID# 162214
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Louisville /ID# 162242
Louisville, Kentucky, United States, 40202
United States, Louisiana
Louisiana Research Ctr. LLC /ID# 162567
Shreveport, Louisiana, United States, 71105-6800
United States, Maryland
Mercy Medical Center /ID# 162291
Baltimore, Maryland, United States, 21202
United States, Minnesota
Mayo Clinic - Rochester /ID# 162251
Rochester, Minnesota, United States, 55905-0001
United States, Mississippi
Southern Therapy and Advanced Research (STAR) LLC /ID# 162241
Jackson, Mississippi, United States, 39216
United States, Nebraska
CHI Health Alegent Creighton /ID# 162286
Omaha, Nebraska, United States, 68124
Univ Nebraska Med Ctr /ID# 162285
Omaha, Nebraska, United States, 68198
United States, New Jersey
Rnjms /Id# 162213
Newark, New Jersey, United States, 07103
United States, New York
Montefiore Medical Center /ID# 162312
Bronx, New York, United States, 10461
James J. Peters VA Medical Center /ID# 162644
Bronx, New York, United States, 10468
Weill Cornell Medical College /ID# 161051
New York, New York, United States, 10021
Icahn School of Med Mt. Sinai /ID# 162294
New York, New York, United States, 10029
United States, North Carolina
Duke University Medical Center /ID# 162299
Durham, North Carolina, United States, 27710-3000
Cumberland Research Assoc /ID# 162212
Fayetteville, North Carolina, United States, 28304
Carolinas Center for Liver Dis /ID# 162569
Statesville, North Carolina, United States, 28677-3471
United States, Ohio
University Hospitals Cleveland /ID# 162243
Cleveland, Ohio, United States, 44106
Cleveland Clinic /ID# 162570
Cleveland, Ohio, United States, 44111
United States, Oklahoma
Osuchs /Id# 162284
Tulsa, Oklahoma, United States, 74127
United States, Pennsylvania
Lehigh Valley Health Network /ID# 162603
Allentown, Pennsylvania, United States, 18103
Center for Liver Diseases, Oakland /ID# 162568
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt Univ Med Ctr /ID# 162211
Nashville, Tennessee, United States, 37232-0011
United States, Texas
Texas Digestive Disease Consul /ID# 162648
Dallas, Texas, United States, 75246-1613
University of Texas Health /ID# 162288
Houston, Texas, United States, 77030-1501
United States, Virginia
Virginia Commonwealth Univ /ID# 162215
Richmond, Virginia, United States, 23219
United States, Wisconsin
Univ of Wisconsin Hosp/Clinics /ID# 162645
Madison, Wisconsin, United States, 53792-0001
Bulgaria
Tokuda Hospital Sofia /ID# 163422
Sofia, Bulgaria, 1407
DCC Fokus-5 - LZIP /ID# 163338
Sofia, Bulgaria, 1463
Univ Hosp for Active Treat /ID# 163330
Sofia, Bulgaria, 1527
UMHAT Sv. Ivan Rilski /ID# 163332
Sofia, Bulgaria, 1612
Canada, Alberta
University of Calgary /ID# 161185
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
Percuro Clinical Research, Ltd /ID# 161184
Victoria, British Columbia, Canada, V8V 3M9
Canada, Nova Scotia
Qe Ii Hsc /Id# 161178
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
The Ottawa Hospital Research /ID# 161179
Ottawa, Ontario, Canada, K1H 8L6
Toronto General Hospital /ID# 161182
Toronto, Ontario, Canada, M5G 2C4
Czechia
Research Site s.r.o /ID# 163020
Plzen, Czechia, 301 00
KlinMed s.r.o. /ID# 162893
Prague, Czechia, 120 00
Institut Klinicke a Experimeth /ID# 162900
Prague, Czechia, 140 21
France
CHR Orleans - Hopital de la Source /ID# 163072
Orleans CEDEX 2, Centre-Val De Loire, France, 45067
Hôpital Purpan /ID# 163065
TOULOUSE Cedex 9, Haute-Garonne, France, 31059
CHU Amiens Picardie /ID# 163071
Amiens CEDEX 1, Somme, France, 80054
CHU Estaing /ID# 163058
Clermont Ferrand, France, 63100
Hospital Henri Mondor /ID# 163061
Creteil, France, 94010
Hopital de la Croix Rousse /ID# 163073
Lyon, France, 69004
Greece
General Hospital of Athens Laiko /ID# 162786
Athens, Attiki, Greece, 115 27
General and Oncology Hospital /ID# 162784
Kifissia, Greece, 14564
Reg Gen Univ Hosp Larissa /ID# 162783
Larisa, Greece, 41110
Bioclinic Thessaloniki /ID# 162785
Thessaloniki, Greece, 54622
Hungary
Budai Hepatologiai Centrum /ID# 166511
Budapest, Hungary, 1111
Szent Janos Korhaz /ID# 166542
Budapest, Hungary, 1125
Ireland
St. James's Hospital /ID# 162619
Dublin 8, Dublin, Ireland, D08 E9P6
St Vincent's Hospital /ID# 162617
Dublin 4, Ireland
Beaumont Hospital /ID# 162618
Dublin, Ireland, D09 XR63
Israel
Tel Aviv Sourasky Medical Ctr /ID# 162185
Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
Rambam Health Care Campus /ID# 162023
Haifa, Israel, 3109601
The Lady Davis Carmel MC /ID# 162017
Haifa, Israel, 3436212
Sheba Medical Center /ID# 162028
Ramat Gan, Israel, 5262100
Italy
Universita della Campania Luigi Vanvitelli /ID# 162337
Napoli, Campania, Italy, 80131
A.O.U. Policlinico S.Orsola-Malpighi /ID# 162335
Bologna, Emilia-Romagna, Italy, 40138
ASST Grande Ospedale Metropolitano Niguarda /ID# 162340
Milano, Lombardia, Italy, 20162
Istituto Clinico Humanitas /ID# 162336
Rozzano, Milano, Italy, 20089
Polo Universitario Luigi Sacco /ID# 162339
Milan, Italy, 20157
Poland
Centrum Badan Klinicznych, Przychodnia Badan Klinicznych /ID# 162760
Wrocław, Dolnoslaskie, Poland, 50-349
HepID - Diagnostyka I Terapia /ID# 162761
Lublin, Lubelskie, Poland, 20-884
Uniwersytecki Szpital Kliniczn /ID# 162757
Bialystok, Poland, 15-276
ID Clinic /ID# 162759
Myslowice, Poland, 41-406
Portugal
Centro Hosp de Lisboa Central /ID# 163770
Lisbon, Lisboa, Portugal, 1169-050
Centro Hospitalar Lisboa Norte, EPE /ID# 163785
Lisboa, Portugal, 1649-035
Centro Hospitalar do Porto EPE /ID# 163765
Porto, Portugal, 4099-001
Centro Hospitalar de Sao Joao /ID# 163766
Porto, Portugal, 4200-319
Puerto Rico
GHGCPR Research Institute /ID# 162608
Ponce, Puerto Rico, 00716
Instituto de Investigacion Cientifica del Sur /ID# 162566
Ponce, Puerto Rico, 00730
Klinical Investigations Group /ID# 162565
San Juan, Puerto Rico, 00909
Romania
Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 163484
Sector 2, Bucuresti, Romania, 021105
Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 164449
Sector 2, Bucuresti, Romania, 021105
Institutul Clinic Fundeni /ID# 163479
Sector 2, Bucuresti, Romania, 022328
Institutul Clinic Fundeni /ID# 163500
Sector 2, Bucuresti, Romania, 022328
Institutul Nat. de Boli Infectioase /ID# 163488
Bucuresti, Romania, 010825
Russian Federation
LLC Medical Company Hepatolog /ID# 161998
Samara, Samarskaya Oblast, Russian Federation, 443063
CBSI Central scientific and research institute of epidemiology /ID# 161996
Moscow, Russian Federation, 105275
Central Clinical Hospital of R /ID# 163434
Moscow, Russian Federation, 117593
Stavropol State Medical Univ /ID# 161999
Stavropol, Russian Federation, 355017
RSAHI Consulting and Diagnostic Centre /ID# 161995
Tyumen, Russian Federation, 625026
Spain
Hospital Parc de Salut del Mar /ID# 162198
Barcelona, Spain, 08003
Hospital Univ Vall d'Hebron /ID# 162199
Barcelona, Spain, 08035
Hospital Universitario Reina S /ID# 162200
Cordoba, Spain, 14004
Hospital Donostia /ID# 162197
Donostia, Spain, 20080
Hospital Univ Central Asturias /ID# 162195
Oviedo, Spain, 33011
Taiwan
China Medical University Hosp /ID# 162950
Taichung City, Taichung, Taiwan, 40447
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 162949
Kaohsiung, Taiwan, 80708
Taipei Veterans General Hosp /ID# 162776
Taipei City, Taiwan, 11217
United Kingdom
Basildon University Hospital /ID# 162616
Basildon, Essex, United Kingdom, SS16 5NL
The Royal Free Hospital /ID# 162614
London, London, City Of, United Kingdom, NW3 2QG
North Manchester General /ID# 163945
Crumpsall, United Kingdom, M8 5RB
Western General Hospital /ID# 162612
Edinburgh, United Kingdom, EH4 2XU
Queens Medical Centre /ID# 162615
Nottinghamshire, United Kingdom, NG7 2UH
Vietnam
National Hospital of Tropical Diseases /ID# 167974
Hanoi, Vietnam, 100000
Hoa Hao Medic Co. Ltd. /ID# 168178
Ho Chi Minh, Vietnam, 700000
Tropical Diseases Hospital /ID# 168211
Ho Chi Minh, Vietnam, 700000
Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Study Protocol  [PDF] June 11, 2018
Statistical Analysis Plan  [PDF] August 8, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03089944    
Other Study ID Numbers: M16-135
2016-004967-38 ( EudraCT Number )
First Posted: March 24, 2017    Key Record Dates
Results First Posted: July 13, 2020
Last Update Posted: July 13, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Hepatitis C Virus (HCV)
Glecaprevir
Pibrentasvir
Treatment Naïve
Cirrhosis
Compensated Cirrhosis
Genotype (GT) 1-6
Pangenotypic
Chronic Hepatitis C Virus (HCV)
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes