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

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ClinicalTrials.gov Identifier: NCT03089944
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
A Phase 3b, single arm, open-label, multicenter study to evaluate the safety and to demonstrate the non-inferiority of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with the glecaprevir (GLE)/pibrentasvir (PIB) combination regimen to the historical SVR12 rate of 12 weeks of treatment with the GLE/PIB in treatment-naïve adults with chronic HCV Genotype 1-6 infection and compensated cirrhosis.

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

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
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
Estimated Primary Completion Date : May 18, 2019
Estimated Study Completion Date : November 2, 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 the per protocol 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]) 12 weeks after the last dose of study drug.

  2. Percentage of Participants With SVR12 in the intent-to-treat population [ Time Frame: 12 weeks after last dose of study drug ]
    SVR12 was defined as HCV RNA level less than the LLOQ 12 weeks after the last dose of study drug in the intent-to-treat population.


Secondary Outcome Measures :
  1. Percentage of Participants with On-treatment Virologic Failure [ Time Frame: Up to 12 weeks while on treatment ]
    On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.

  2. 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 with HCV RNA levels < LLOQ at the end of treatment, excluding participants who have been shown to be re-infected.



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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) 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


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

  Hide Study Locations
Locations
United States, Arizona
St. Josephs Hosp and Med Ctr /ID# 162762 Recruiting
Phoenix, Arizona, United States, 85013
Mayo Clinic Arizona /ID# 162314 Recruiting
Phoenix, Arizona, United States, 85054
United States, Arkansas
Liver Wellness Center /ID# 162244 Recruiting
Little Rock, Arkansas, United States, 72204
United States, California
Felizarta /ID# 162295 Recruiting
Bakersfield, California, United States, 93301
VA Long Beach Healthcare System /ID# 162298 Recruiting
Long Beach, California, United States, 90822
Usc /Id# 162248 Recruiting
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Ctr /ID# 162313 Recruiting
Los Angeles, California, United States, 90048
Kaiser Permanente /ID# 162289 Active, not recruiting
San Diego, California, United States, 92154
Stanford Univ School of Med /ID# 162209 Recruiting
Stanford, California, United States, 94305-2200
United States, Florida
University of Miami /ID# 162210 Active, not recruiting
Miami, Florida, United States, 33136
Triple O Research Institute /ID# 162300 Recruiting
West Palm Beach, Florida, United States, 33407-3100
United States, Georgia
Piedmont Hospital /ID# 162646 Active, not recruiting
Atlanta, Georgia, United States, 30309
United States, Illinois
Northwestern University /ID# 162208 Recruiting
Chicago, Illinois, United States, 60611-2927
United States, Iowa
Unity Point Health /ID# 162247 Not yet recruiting
Des Moines, Iowa, United States, 50309
The University of Iowa Hospita /ID# 162214 Recruiting
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Louisville /ID# 162242 Not yet recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Louisiana Research Ctr. LLC /ID# 162567 Active, not recruiting
Shreveport, Louisiana, United States, 71105-6800
United States, Maryland
Mercy Medical Center /ID# 162291 Active, not recruiting
Baltimore, Maryland, United States, 21202
United States, Minnesota
Mayo Clinic - Rochester /ID# 162251 Not yet recruiting
Rochester, Minnesota, United States, 55905-0001
United States, Mississippi
Southern Therapy and Advanced Research (STAR) LLC /ID# 162241 Recruiting
Jackson, Mississippi, United States, 39216
United States, Nebraska
CHI Health Alegent Creighton /ID# 162286 Recruiting
Omaha, Nebraska, United States, 68124
Univ Nebraska Med Ctr /ID# 162285 Recruiting
Omaha, Nebraska, United States, 68198
United States, New Jersey
Rnjms /Id# 162213 Not yet recruiting
Newark, New Jersey, United States, 07103
United States, New York
Montefiore Medical Center /ID# 162312 Recruiting
Bronx, New York, United States, 10461
James J. Peters VA Medical Center /ID# 162644 Not yet recruiting
Bronx, New York, United States, 10468
Weill Cornell Medical College /ID# 161051 Recruiting
New York, New York, United States, 10021
Icahn School of Med Mt. Sinai /ID# 162294 Recruiting
New York, New York, United States, 10029
United States, North Carolina
Duke Univ Med Ctr /ID# 162299 Recruiting
Durham, North Carolina, United States, 27710
Cumberland Research Assoc /ID# 162212 Active, not recruiting
Fayetteville, North Carolina, United States, 28304
Carolinas Center for Liver Dis /ID# 162569 Recruiting
Huntersville, North Carolina, United States, 28078
United States, Ohio
University Hospitals Cleveland /ID# 162243 Active, not recruiting
Cleveland, Ohio, United States, 44106
Cleveland Clinic /ID# 162570 Not yet recruiting
Cleveland, Ohio, United States, 44111
United States, Oklahoma
OSU Center for Health Sciences /ID# 162284 Recruiting
Tulsa, Oklahoma, United States, 74127
United States, Pennsylvania
Lehigh Valley Health Network /ID# 162603 Recruiting
Allentown, Pennsylvania, United States, 18103
Center for Liver Diseases /ID# 162568 Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt Univ Med Ctr /ID# 162211 Recruiting
Nashville, Tennessee, United States, 37232-0011
United States, Texas
Texas Digestive Disease Consul /ID# 162648 Recruiting
Dallas, Texas, United States, 75246-1613
University of Texas Health /ID# 162288 Active, not recruiting
Houston, Texas, United States, 77030-1501
United States, Virginia
Virginia Commonwealth Univ /ID# 162215 Active, not recruiting
Richmond, Virginia, United States, 23219
United States, Wisconsin
Univ of Wisconsin Hosp/Clinics /ID# 162645 Recruiting
Madison, Wisconsin, United States, 53792-0001
Bulgaria
Tokuda Hospital Sofia /ID# 163422 Recruiting
Sofia, Bulgaria, 1407
DCC Fokus-5 - LZIP /ID# 163338 Recruiting
Sofia, Bulgaria, 1463
Univ Hosp for Active Treat /ID# 163330 Recruiting
Sofia, Bulgaria, 1527
UMHAT Sv. Ivan Rilski /ID# 163332 Recruiting
Sofia, Bulgaria, 1612
Canada, Alberta
University of Calgary /ID# 161185 Active, not recruiting
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
Percuro Clinical Research, Ltd /ID# 161184 Active, not recruiting
Victoria, British Columbia, Canada, V8V 3M9
Canada, Nova Scotia
Qe Ii Hsc /Id# 161178 Active, not recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
The Ottawa Hospital Research /ID# 161179 Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Toronto General Hospital /ID# 161182 Recruiting
Toronto, Ontario, Canada, M5G 2C4
Czechia
Researchsite S.R.O. /ID# 163020 Recruiting
Plzen, Czechia, 30100
KlinMed s.r.o. /ID# 162893 Recruiting
Prague, Czechia, 120 00
Institut Klinicke a Experimeth /ID# 162900 Recruiting
Prague, Czechia, 140 21
France
CHR Orleans - Hopital de la Source /ID# 163072 Active, not recruiting
Orleans CEDEX 2, Centre-Val De Loire, France, 45067
Hôpital Purpan /ID# 163065 Active, not recruiting
TOULOUSE Cedex 9, Haute-Garonne, France, 31059
CHU Amiens Picardie /ID# 163071 Not yet recruiting
Amiens CEDEX 1, Somme, France, 80054
CHU Estaing /ID# 163058 Active, not recruiting
Clermont Ferrand, France, 63100
Hospital Henri Mondor /ID# 163061 Recruiting
Creteil, France, 94010
Hopital de la Croix Rousse /ID# 163073 Active, not recruiting
Lyon, France, 69004
Greece
General Hospital of Athens Laiko /ID# 162786 Recruiting
Athens, Attiki, Greece, 115 27
General and Oncology Hospital /ID# 162784 Not yet recruiting
Kifissia, Greece, 14564
Reg Gen Univ Hosp Larissa /ID# 162783 Not yet recruiting
Larisa, Greece, 41110
Bioclinic Thessaloniki /ID# 162785 Not yet recruiting
Thessaloniki, Greece, 54622
Hungary
Budai Hepatologiai Centrum /ID# 166511 Recruiting
Budapest, Hungary, 1111
Szent Janos Korhaz /ID# 166542 Recruiting
Budapest, Hungary, 1125
Ireland
St. James's Hospital /ID# 162619 Active, not recruiting
Dublin 8, Dublin, Ireland, D08 E9P6
St Vincent's Hospital /ID# 162617 Active, not recruiting
Dublin 4, Ireland
Beaumont Hospital /ID# 162618 Active, not recruiting
Dublin, Ireland, D09 XR63
Israel
Tel Aviv Sourasky Medical Ctr /ID# 162185 Active, not recruiting
Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
Rambam Health Care Campus /ID# 162023 Active, not recruiting
Haifa, Israel, 3109601
The Lady Davis Carmel MC /ID# 162017 Active, not recruiting
Haifa, Israel, 3436212
Sheba Medical Center /ID# 162028 Active, not recruiting
Ramat Gan, Israel, 5262100
Italy
Universita della Campania Luigi Vanvitelli /ID# 162337 Recruiting
Napoli, Campania, Italy, 80131
A.O.U. Policlinico S.Orsola-Malpighi /ID# 162335 Recruiting
Bologna, Emilia-Romagna, Italy, 40138
ASST Grande Ospedale Metropolitano Niguarda /ID# 162340 Recruiting
Milano, Lombardia, Italy, 20162
Istituto Clinico Humanitas /ID# 162336 Recruiting
Rozzano, Milano, Italy, 20089
Polo Universitario Luigi Sacco /ID# 162339 Recruiting
Milan, Italy, 20157
Poland
Centrum Badan Klinicznych, Przychodnia Badan Klinicznych /ID# 162760 Recruiting
Wrocław, Dolnoslaskie, Poland, 50-349
HepID - Diagnostyka I Terapia /ID# 162761 Recruiting
Lublin, Lubelskie, Poland, 20-884
Uniwersytecki Szpital Kliniczn /ID# 162757 Recruiting
Bialystok, Poland, 15-276
ID Clinic /ID# 162759 Recruiting
Myslowice, Poland, 41-406
Portugal
Centro Hosp de Lisboa Central /ID# 163770 Active, not recruiting
Lisbon, Lisboa, Portugal, 1169-050
Centro Hospitalar Lisboa Norte, EPE /ID# 163785 Active, not recruiting
Lisboa, Portugal, 1649-035
Centro Hospitalar do Porto EPE /ID# 163765 Active, not recruiting
Porto, Portugal, 4099-001
Centro Hospitalar de Sao Joao /ID# 163766 Active, not recruiting
Porto, Portugal, 4200-319
Puerto Rico
GHGCPR Research Institute /ID# 162608 Recruiting
Ponce, Puerto Rico, 00716
Instituto de Investigacion Cie /ID# 162566 Recruiting
Ponce, Puerto Rico, 00730
Klinical Investigations Group /ID# 162565 Active, not recruiting
San Juan, Puerto Rico, 00909
Romania
Clinic Fundeni Institute /ID# 163479 Recruiting
Bucharest, Bucuresti, Romania, 022328
Clinic Fundeni Institute /ID# 163500 Recruiting
Bucharest, Bucuresti, Romania, 022328
Institutul Nat. de Boli Infectioase /ID# 163488 Recruiting
Bucuresti, Romania, 010825
Inst Nat Boli Infect M Bals /ID# 163484 Recruiting
Bucuresti, Romania, 021105
Inst Nat Boli Infect M Bals /ID# 164449 Recruiting
Bucuresti, Romania, 021105
Russian Federation
LLC Medical Company Hepatolog /ID# 161998 Recruiting
Samara, Samarskaya Oblast, Russian Federation, 443063
Ctr Scie Res Inst Epidemiology /ID# 161996 Recruiting
Moscow, Russian Federation, 105275
Central Clinical Hospital of R /ID# 163434 Recruiting
Moscow, Russian Federation, 117593
Stavropol State Medical Univ /ID# 161999 Recruiting
Stavropol, Russian Federation, 355017
Consulting and Diagnostic Cent /ID# 161995 Recruiting
Tyumen, Russian Federation, 625026
Spain
Hospital Parc de Salut del Mar /ID# 162198 Recruiting
Barcelona, Spain, 08003
Hospital Univ Vall d'Hebron /ID# 162199 Recruiting
Barcelona, Spain, 08035
Hospital Universitario Reina S /ID# 162200 Recruiting
Cordoba, Spain, 14004
Hospital Donostia /ID# 162197 Recruiting
Donostia, Spain, 20080
Hospital Univ Central Asturias /ID# 162195 Recruiting
Oviedo, Spain, 33011
Taiwan
China Medical University Hosp /ID# 162950 Recruiting
Taichung City, Taichung, Taiwan, 40447
Kaohsiung Medical University /ID# 162949 Recruiting
Kaohsiung, Taiwan, 80708
Taipei Veterans General Hosp /ID# 162776 Recruiting
Taipei City, Taiwan, 11217
United Kingdom
Basildon University Hospital /ID# 162616 Recruiting
Basildon, Essex, United Kingdom, SS16 5NL
The Royal Free Hospital /ID# 162614 Recruiting
London, London, City Of, United Kingdom, NW3 2QG
North Manchester General /ID# 163945 Recruiting
Crumpsall, United Kingdom, M8 5RB
Western General Hospital /ID# 162612 Not yet recruiting
Edinburgh, United Kingdom, EH4 2XU
Queens Medical Centre /ID# 162615 Recruiting
Nottinghamshire, United Kingdom, NG7 2UH
Vietnam
National Tropical Diseases Hos /ID# 167974 Recruiting
Hanoi, Vietnam, 100000
Hoa Hao Medic Co. Ltd. /ID# 168178 Recruiting
Ho Chi Minh, Vietnam, 700000
Tropical Diseases Hospital /ID# 168211 Recruiting
Ho Chi Minh, Vietnam, 700000
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03089944     History of Changes
Other Study ID Numbers: M16-135
2016-004967-38 ( EudraCT Number )
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Fibrosis
Liver Cirrhosis
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes