Hepatitis C Virus (HCV)Phase 3EXPEDITION-8NCT03089944
A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
A Phase 3 study testing Glecaprevir/Pibrentasvir in people with Hepatitis C Virus (HCV), run by AbbVie at 113 sites in 19 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus (HCV)
- What is being tested?
- Glecaprevir/Pibrentasvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 343 participants
- Where
- 113 sitesin 19 countries
- Study dates
- 28 Apr 2017to 8 Nov 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
113 sites in 19 countries.
113 sites in 19 countries
United States40 sites
Lehigh Valley Health Network /ID# 162603
Allentown, Pennsylvania, 18103
Piedmont Hospital /ID# 162646
Atlanta, Georgia, 30309
Felizarta /ID# 162295
Bakersfield, California, 93301
Mercy Medical Center /ID# 162291
Baltimore, Maryland, 21202
Northwestern University Feinberg School of Medicine /ID# 162208
Chicago, Illinois, 60611-2927
University Hospitals Cleveland /ID# 162243
Cleveland, Ohio, 44106
Cleveland Clinic /ID# 162570
Cleveland, Ohio, 44111
Texas Digestive Disease Consul /ID# 162648
Dallas, Texas, 75246-1613
Unity Point Health /ID# 162247
Des Moines, Iowa, 50309
Duke University Medical Center /ID# 162299
Durham, North Carolina, 27710-3000
Cumberland Research Assoc /ID# 162212
Fayetteville, North Carolina, 28304
University of Texas Health /ID# 162288
Houston, Texas, 77030-1501
The University of Iowa Hospita /ID# 162214
Iowa City, Iowa, 52242
Southern Therapy and Advanced Research (STAR) LLC /ID# 162241
Jackson, Mississippi, 39216
Liver Wellness Center /ID# 162244
Little Rock, Arkansas, 72204
VA Long Beach Healthcare System /ID# 162298
Long Beach, California, 90822
Usc /Id# 162248
Los Angeles, California, 90033
University of Louisville /ID# 162242
Louisville, Kentucky, 40202
Univ of Wisconsin Hosp/Clinics /ID# 162645
Madison, Wisconsin, 53792-0001
University of Miami /ID# 162210
Miami, Florida, 33136
Vanderbilt Univ Med Ctr /ID# 162211
Nashville, Tennessee, 37232-0011
Weill Cornell Medical College /ID# 161051
New York, New York, 10021
Icahn School of Med Mt. Sinai /ID# 162294
New York, New York, 10029
Rnjms /Id# 162213
Newark, New Jersey, 07103
CHI Health Alegent Creighton /ID# 162286
Omaha, Nebraska, 68124
Univ Nebraska Med Ctr /ID# 162285
Omaha, Nebraska, 68198
St. Josephs Hosp and Med Ctr /ID# 162762
Phoenix, Arizona, 85013
Mayo Clinic Arizona /ID# 162314
Phoenix, Arizona, 85054
Center for Liver Diseases, Oakland /ID# 162568
Pittsburgh, Pennsylvania, 15213
Virginia Commonwealth Univ /ID# 162215
Richmond, Virginia, 23219
Mayo Clinic - Rochester /ID# 162251
Rochester, Minnesota, 55905-0001
Kaiser Permanente - San Diego (Palm Ave) /ID# 162289
San Diego, California, 92154
Louisiana Research Ctr. LLC /ID# 162567
Shreveport, Louisiana, 71105-6800
Stanford University School of Med /ID# 162209
Stanford, California, 94305-2200
Carolinas Center for Liver Dis /ID# 162569
Statesville, North Carolina, 28677-3471
Montefiore Medical Center /ID# 162312
The Bronx, New York, 10461
James J. Peters VA Medical Center /ID# 162644
The Bronx, New York, 10468
Osuchs /Id# 162284
Tulsa, Oklahoma, 74127
Cedars-Sinai Medical Center - West Hollywood /ID# 162313
West Hollywood, California, 90048
Triple O Research Institute /ID# 162300
West Palm Beach, Florida, 33407-3100
France6 sites
CHU Amiens Picardie /ID# 163071
Amiens, Somme, 80054
CHU Estaing /ID# 163058
Clermont-Ferrand, 63100
Hospital Henri Mondor /ID# 163061
Créteil, 94010
Hopital de la Croix Rousse /ID# 163073
Lyon, 69004
CHR Orleans - Hopital de la Source /ID# 163072
Orléans, Centre-Val de Loire, 45067
Hôpital Purpan /ID# 163065
Toulouse, Haute-Garonne, 31059
Canada5 sites
University of Calgary /ID# 161185
Calgary, Alberta, T2N 4Z6
Qe Ii Hsc /Id# 161178
Halifax, Nova Scotia, B3H 1V7
The Ottawa Hospital Research /ID# 161179
Ottawa, Ontario, K1H 8L6
Toronto General Hospital /ID# 161182
Toronto, Ontario, M5G 2C4
Percuro Clinical Research, Ltd /ID# 161184
Victoria, British Columbia, V8V 3M9
Italy5 sites
A.O.U. Policlinico S.Orsola-Malpighi /ID# 162335
Bologna, Emilia-Romagna, 40138
ASST Grande Ospedale Metropolitano Niguarda /ID# 162340
Milan, Lombardy, 20162
Polo Universitario Luigi Sacco /ID# 162339
Milan, 20157
Universita della Campania Luigi Vanvitelli /ID# 162337
Naples, Campania, 80131
Istituto Clinico Humanitas /ID# 162336
Rozzano, Milano, 20089
Romania5 sites
Institutul Nat. de Boli Infectioase /ID# 163488
Bucharest, 010825
Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 163484
Sector 2, Bucharest, 021105
Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 164449
Sector 2, Bucharest, 021105
Institutul Clinic Fundeni /ID# 163479
Sector 2, Bucharest, 022328
Institutul Clinic Fundeni /ID# 163500
Sector 2, Bucharest, 022328
Russia5 sites
CBSI Central scientific and research institute of epidemiology /ID# 161996
Moscow, 105275
Central Clinical Hospital of R /ID# 163434
Moscow, 117593
LLC Medical Company Hepatolog /ID# 161998
Samara, Samara Oblast, 443063
Stavropol State Medical Univ /ID# 161999
Stavropol, 355017
RSAHI Consulting and Diagnostic Centre /ID# 161995
Tyumen, 625026
Spain5 sites
Hospital Parc de Salut del Mar /ID# 162198
Barcelona, 08003
Hospital Univ Vall d'Hebron /ID# 162199
Barcelona, 08035
Hospital Universitario Reina S /ID# 162200
Córdoba, 14004
Hospital Donostia /ID# 162197
Donostia / San Sebastian, 20080
Hospital Univ Central Asturias /ID# 162195
Oviedo, 33011
United Kingdom5 sites
Basildon University Hospital /ID# 162616
Basildon, Essex, SS16 5NL
North Manchester General /ID# 163945
Crumpsall, M8 5RB
Western General Hospital /ID# 162612
Edinburgh, EH4 2XU
The Royal Free Hospital /ID# 162614
London, London, City of, NW3 2QG
Queens Medical Centre /ID# 162615
Nottinghamshire, NG7 2UH
Bulgaria4 sites
Tokuda Hospital Sofia /ID# 163422
Sofia, 1407
DCC Fokus-5 - LZIP /ID# 163338
Sofia, 1463
Univ Hosp for Active Treat /ID# 163330
Sofia, 1527
UMHAT Sv. Ivan Rilski /ID# 163332
Sofia, 1612
Greece4 sites
General Hospital of Athens Laiko /ID# 162786
Athens, Attica, 115 27
General and Oncology Hospital /ID# 162784
Kifissia, 14564
Reg Gen Univ Hosp Larissa /ID# 162783
Larissa, 41110
Bioclinic Thessaloniki /ID# 162785
Thessaloniki, 54622
Israel4 sites
Rambam Health Care Campus /ID# 162023
Haifa, 3109601
The Lady Davis Carmel MC /ID# 162017
Haifa, 3436212
Sheba Medical Center /ID# 162028
Ramat Gan, 5262100
Tel Aviv Sourasky Medical Ctr /ID# 162185
Tel Aviv, Tel Aviv, 6423906
Poland4 sites
Uniwersytecki Szpital Kliniczn /ID# 162757
Bialystok, 15-276
HepID - Diagnostyka I Terapia /ID# 162761
Lublin, Lublin Voivodeship, 20-884
ID Clinic /ID# 162759
Mysłowice, 41-406
Centrum Badan Klinicznych, Przychodnia Badan Klinicznych /ID# 162760
Wroclaw, Lower Silesian Voivodeship, 50-349
Portugal4 sites
Centro Hosp de Lisboa Central /ID# 163770
Lisbon, Lisbon District, 1169-050
Centro Hospitalar Lisboa Norte, EPE /ID# 163785
Lisbon, 1649-035
Centro Hospitalar do Porto EPE /ID# 163765
Porto, 4099-001
Centro Hospitalar de Sao Joao /ID# 163766
Porto, 4200-319
Czechia3 sites
Research Site s.r.o /ID# 163020
Pilsen, 301 00
KlinMed s.r.o. /ID# 162893
Prague, 120 00
Institut Klinicke a Experimeth /ID# 162900
Prague, 140 21
Ireland3 sites
St. James's Hospital /ID# 162619
Dublin, Dublin, D08 E9P6
Beaumont Hospital /ID# 162618
Dublin, D09 XR63
St Vincent's Hospital /ID# 162617
Dublin
Puerto Rico3 sites
GHGCPR Research Institute /ID# 162608
Ponce, 00716
Instituto de Investigacion Cientifica del Sur /ID# 162566
Ponce, 00730
Klinical Investigations Group /ID# 162565
San Juan, 00909
Taiwan3 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 162949
Kaohsiung City, 80708
China Medical University Hosp /ID# 162950
Taichung, Taichung, 40447
Taipei Veterans General Hosp /ID# 162776
Taipei, 11217
Vietnam3 sites
National Hospital of Tropical Diseases /ID# 167974
Hanoi, 100000
Hoa Hao Medic Co. Ltd. /ID# 168178
Ho Chi Minh City, 700000
Tropical Diseases Hospital /ID# 168211
Ho Chi Minh City, 700000
Hungary2 sites
Budai Hepatologiai Centrum /ID# 166511
Budapest, 1111
Szent Janos Korhaz /ID# 166542
Budapest, 1125
About this study
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
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.
- Conditions
- Hepatitis C Virus (HCV)
- Being tested
- Glecaprevir/Pibrentasvir
- Keywords
- Hepatitis C Virus (HCV), Glecaprevir, Pibrentasvir, Treatment Naïve, Cirrhosis, Compensated Cirrhosis, Genotype (GT) 1-6, Pangenotypic, Chronic Hepatitis C Virus (HCV)
- Medical subject headings
- Hepatitis C, Fibrosis, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glecaprevir/PibrentasvirDrug
Also called ABT-493, ABT-530
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks | Experimental | Glecaprevir (GLE)/Pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks. Receives: Drug: Glecaprevir/Pibrentasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 12 weeks after last dose of study drug
Percentage of Participants With SVR12 in HCV GT 1,2,4,5 and 6-infected Participants in the Intent-To-Treat (ITT) Population
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.
Measured: 12 weeks after last dose of study drug
Secondary outcomes (6)
Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the PP Population
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.
Measured: 12 weeks after last dose of study drug
Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the ITT Population
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.
Measured: 12 weeks after the last dose of study drug
Percentage of Participants With On-treatment Virologic Failure in the ITT Population
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.
Measured: 8 weeks on treatment
Percentage of Participants With Post-treatment Relapse
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.
Measured: Up to 12 weeks after the last dose of study drug
Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the PP Population
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.
Measured: 12 weeks after the last dose of study drug
Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the ITT Population
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.
Measured: 12 weeks after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start28 Apr 2017
- Primary completion31 Jul 2019
- Study completion8 Nov 2019
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 Virus (HCV)Studies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089944
- Sponsor's protocol ID
- M16-135
- Other IDs
- 2016-004967-38, 2016
- Acronym
- EXPEDITION-8
- Status last verified
- Jun 2020
- First submitted
- 22 Mar 2017
- Last updated
- 13 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
- Expanded access
- Available
Publications
Brown RS Jr, Buti M, Rodrigues L, Chulanov V, Chuang WL, Aguilar H, Horvath G, Zuckerman E, Carrion BR, Rodriguez-Perez F, Urbanek P, Abergel A, Cohen E, Lovell SS, Schnell G, Lin CW, Zha J, Wang S, Trinh R, Mensa FJ, Burroughs M, Felizarta F. Glecaprevir/pibrentasvir for 8 weeks in treatment-naive patients with chronic HCV genotypes 1-6 and compensated cirrhosis: The EXPEDITION-8 trial. J Hepatol. 2020 Mar;72(3):441-449. doi: 10.1016/j.jhep.2019.10.020. Epub 2019 Nov 2.
PubMed 31682879
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03089944
- Acronym / sponsor ID
- EXPEDITION-8 / M16-135
- Conditions
- Hepatitis C Virus (HCV)
- Keywords
- Hepatitis C Virus (HCV), Glecaprevir, Pibrentasvir, Treatment Naïve, Cirrhosis, Compensated Cirrhosis, Genotype (GT) 1-6, Pangenotypic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Posted 13 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks | Experimental | Drug: Glecaprevir/PibrentasvirGlecaprevir (GLE)/Pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Glecaprevir/PibrentasvirAlso: ABT-493, ABT-530Tablet | Drug | Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks |
Primary outcome
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.
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.
6 secondary outcomes
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
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
Percentage of Participants With On-treatment Virologic Failure in the ITT Population
Time frame: 8 weeks on treatment
Percentage of Participants With Post-treatment Relapse
Time frame: Up to 12 weeks after the last dose of study drug
Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the PP Population
Time frame: 12 weeks after the last dose of study drug
Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the ITT Population
Time frame: 12 weeks after the last dose of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31682879Brown RS Jr, Buti M, Rodrigues L, Chulanov V, Chuang WL, Aguilar H, Horvath G, Zuckerman E, Carrion BR, Rodriguez-Perez F, Urbanek P, Abergel A, Cohen E, Lovell SS, Schnell G, Lin CW, Zha J, Wang S, Trinh R, Mensa FJ, Burroughs M, Felizarta F. Glecaprevir/pibrentasvir for 8 weeks in treatment-naive patients with chronic HCV genotypes 1-6 and compensated cirrhosis: The EXPEDITION-8 trial. J Hepatol. 2020 Mar;72(3):441-449. doi: 10.1016/j.jhep.2019.10.020. Epub 2019 Nov 2.
- Individual participant dataSharing planned: Yes. 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.
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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.
AbbVie Inc. study director
AbbVie
113 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glecaprevir/Pibrentasvir in people with Hepatitis C Virus (HCV), run by AbbVie at 113 sites in 19 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 4 inclusion and 5 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 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 113 sites in United States, France, Canada, Italy, Romania and 14 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 13 Jul 2020). 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 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). The study lists 2 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 NCT03089944, 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 13 Jul 2020.