Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04903626

Collaborator

(none)

283

Enrollment

Locations

Arm

31.4

Anticipated Duration (Months)

4.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hepatitis C Virus (HCV) infection is a global health problem. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and adolescent participants with acute HCV infection.

GLE/PIB is an approved drug for the treatment of chronic HCV. Around 283 participants at least 12 years of age with acute HCV Infection will be enrolled in approximately 70 sites worldwide.

Participants will receive oral tablets of GLE/PIB once daily (QD) for 8 weeks and will be followed for 12 weeks after the end of treatment.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, monitoring for side effects and completing questionnaires.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Virus (HCV)	Drug: Glecaprevir/Pibrentasvir (GLE/PIB)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

283 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Single-Arm Prospective Study to Evaluate Safety and Efficacy of GLE/PIB 8-Week Treatment in Adults and Adolescents With Acute Hepatitis C Virus (HCV) Infection

Actual Study Start Date :

Aug 24, 2021

Anticipated Primary Completion Date :

Apr 5, 2024

Anticipated Study Completion Date :

Apr 5, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants Treated With Glecaprevir/Pibrentasvir for 8 weeks Participants treated once daily with oral tablets of glecaprevir/pibrentasvir for 8 weeks.	Drug: Glecaprevir/Pibrentasvir (GLE/PIB) Oral tablets Other Names: ABT-493/ABT-530 Mavyret

Arm

Intervention/Treatment

Experimental: Participants Treated With Glecaprevir/Pibrentasvir for 8 weeks

Participants treated once daily with oral tablets of glecaprevir/pibrentasvir for 8 weeks.

Drug: Glecaprevir/Pibrentasvir (GLE/PIB)

Oral tablets

Other Names:

ABT-493/ABT-530

Mavyret

Outcome Measures

Primary Outcome Measures

Percentage of Participants With Sustained Virological Response 12 Weeks Post-treatment (SVR12) in the Intention-to-Treat (ITT) Population [12 weeks after last dose of study drug (Week 20)]
SVR12 is defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of the study drug.

Secondary Outcome Measures

Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) in the Modified ITT-Virologic Failure (mITT-VF) Population. [12 weeks after last dose of study drug (Week 20)]
SVR12 is defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of the study drug.
Percentage of Participants With On-Treatment Virologic Failure in the ITT Population [Up to week 8]
On-treatment virologic failure is defined as confirmed increase in HCV RNA of > 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA >= 100 IU/mL after HCV RNA < lower limit of quantification (LLOQ) during treatment, or HCV RNA >= LLOQ at the end of treatment (EOT) with at least 6 weeks of treatment.
Percentage of Participants With Post-Treatment Relapse in the ITT Population [Up to 12 weeks after the last dose of study drug (Week 20)]
Post-treatment (PT) relapse is defined as confirmed HCV RNA >= LLOQ between the end of treatment (EOT) and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < LLOQ at the EOT and with at least 1 PT HCV RNA value, excluding cases of reinfection.
Percentage of Participants With Post-Treatment Reinfection With HCV in the ITT Population [Up to 12 weeks after the last dose of study drug (Week 20)]
Post-treatment (PT) reinfection is defined as confirmed HCV RNA >= LLOQ in the PT period along with the PT detection of a different HCV genotype, subtype, or clade compared with baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Evidence of acute Hepatitis C Virus (HCV) infection prior to enrollment, defined as a physician diagnosis of acute HCV infection with at least 1 of the following:
Negative anti-HCV antibody, HCV Ribonucleic Acid (RNA) and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 8-month period prior to screening; OR
Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 11-month period prior to screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen; OR
Clinical signs and symptoms compatible with acute hepatitis [Alanine aminotransferase (ALT) > 5 × upper limit of normal (ULN) and/or jaundice] in the absence of a history of chronic liver disease or other cause of acute hepatitis and positive HCV RNA or HCV core antigen all within an 8-month period prior to screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen; OR
Negative anti-HCV antibody with a positive HCV RNA or HCV core antigen within a 5-month period prior to screening.
Absence of hepatocellular carcinoma (HCC) for participants with cirrhosis as indicated by a negative ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to screening or a negative ultrasound at screening. Participant who has a positive ultrasound result suspicious of HCC followed by a subsequent negative CT scan or MRI or biopsy result will be eligible for the study.
Participants documented as having no cirrhosis or as having compensated cirrhosis.

Exclusion Criteria:

Participants with prior treatment, including interferon for this HCV infection.
History of liver decompensation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Health Research /ID# 233558	Chandler	Arizona	United States	85225-2906
2	Laboratory Corporation of America Holdings /ID# 228427	Phoenix	Arizona	United States	85040-2969
3	Liver Wellness Center /ID# 244933	Little Rock	Arkansas	United States	72204
4	Velocity Clinical Research Chula Vista /ID# 238352	Chula Vista	California	United States	91911-6658
5	TLC Clinical Research Inc /ID# 232334	Los Angeles	California	United States	90048
6	University of California, Davis Comprehensive Cancer Center /ID# 230814	Sacramento	California	United States	95817
7	Angels Clinical Research Institute /ID# 234090	Doral	Florida	United States	33122-1713
8	Midway Immunology and Research /ID# 229194	Fort Pierce	Florida	United States	34982
9	Midland Research Group, Inc /ID# 231885	Oakland Park	Florida	United States	33334-4434
10	Orlando Immunology Center /ID# 229839	Orlando	Florida	United States	32803
11	Tampa General Hospital /ID# 228930	Tampa	Florida	United States	33606
12	Triple O Research Institute /ID# 229928	West Palm Beach	Florida	United States	33407-3100
13	Florida Medical Clinic /ID# 233489	Zephyrhills	Florida	United States	33542
14	Emory Midtown Infectious Disease Clinic /ID# 229927	Atlanta	Georgia	United States	30322
15	University of Iowa Hospitals and Clinics /ID# 226934	Iowa City	Iowa	United States	52242
16	University of Kentucky Chandler Medical Center /ID# 231588	Lexington	Kentucky	United States	40536
17	University of Louisville Research Foundation Inc /ID# 232139	Louisville	Kentucky	United States	40202-1821
18	Mercy Medical Center /ID# 226937	Baltimore	Maryland	United States	21202
19	Johns Hopkins University /ID# 230694	Baltimore	Maryland	United States	21287
20	Henry Ford Health System /ID# 226932	Detroit	Michigan	United States	48202
21	University of Mississippi Medical Center /ID# 232620	Jackson	Mississippi	United States	39216-4500
22	North Jersey Community Research Initiative (NJCRI) /ID# 245129	Newark	New Jersey	United States	07103-2842
23	Weill Cornell Medical College /ID# 230815	New York	New York	United States	10065
24	Cumberland Research Assoc /ID# 233233	Fayetteville	North Carolina	United States	28304
25	The Christ Hospital /ID# 231204	Cincinnati	Ohio	United States	45219
26	University of Cincinnati /ID# 226922	Cincinnati	Ohio	United States	45267-0585
27	Cherokee Nation Outpatient Health Center /ID# 232618	Tahlequah	Oklahoma	United States	74464-0545
28	Thomas Jefferson University /ID# 232624	Philadelphia	Pennsylvania	United States	19107-4414
29	University Gastroenterology /ID# 233332	Providence	Rhode Island	United States	02905
30	Vanderbilt University Medical Center /ID# 241282	Nashville	Tennessee	United States	37232-0011
31	Liver Associates of Texas, P.A /ID# 229775	Houston	Texas	United States	77030-2783
32	Digestive and Liver Disease Sp /ID# 232633	Norfolk	Virginia	United States	23502
33	Medical College of Wisconsin - Plank Rd /ID# 230116	Milwaukee	Wisconsin	United States	53226-3548
34	Royal Adelaide Hospital /ID# 227167	Adelaide	South Australia	Australia	5000
35	Alfred Health /ID# 227169	Melbourne	Victoria	Australia	3004
36	Universitaetsklinikum St. Poelten /ID# 227098	Sankt Poelten	Niederoesterreich	Austria	3100
37	Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 226985	Linz	Oberoesterreich	Austria	4010
38	Medizinische Universitaet Wien /ID# 226938	Vienna	Wien	Austria	1090
39	Klinik Ottakring /ID# 227141	Vienna	Wien	Austria	1160
40	Vancouver Infectious Diseases Centre /ID# 227125	Vancouver	British Columbia	Canada	V6Z 2C7
41	CoolAid Medical Clinic /ID# 239978	Victoria	British Columbia	Canada	V8W 1M8
42	Charlton Medical Centre /ID# 228100	Hamilton	Ontario	Canada	L8N 1Y2
43	Royal Victoria Hospital / McGill University Health Centre /ID# 227126	Montreal	Quebec	Canada	H4A 3J1
44	CHU Montpellier - Hôpital Saint Eloi /ID# 229083	Montpellier Cedex 5	Herault	France	34295
45	Hopital Beaujon /ID# 246817	Clichy	Ile-de-France	France	92110
46	HCL - Hopital de la Croix-Rousse /ID# 229077	Lyon		France	69004
47	AP-HP - Hopital Saint-Antoine /ID# 229070	Paris		France	75012
48	CH de Tourcoing /ID# 233732	TOURCOING Cedex		France	59208
49	zibp-Zentrum fuer Infektiologie /ID# 226765	Berlin		Germany	10439
50	Universitaetsklinikum Bonn /ID# 226764	Bonn		Germany	53127
51	Infektiologikum /ID# 226880	Frankfurt am Main		Germany	60596
52	ICH Study Center GmbH & Co KG /ID# 228162	Hamburg		Germany	20146
53	Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 226783	Munich		Germany	81675
54	Fondazione PTV Policlinico Tor Vergata /ID# 227078	Rome	Roma	Italy	00133
55	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 227080	Bologna		Italy	40138
56	Azienda Ospedaliera Universitaria Ospedali Riuniti /ID# 227081	Foggia		Italy	71122
57	ASST Grande Ospedale Metropolitano Niguarda /ID# 227079	Milano		Italy	20162
58	Azienda Ospedaliera Universitaria Federico II /ID# 227183	Napoli		Italy	80131
59	Hospital Universitario Germans Trias i Pujol /ID# 226698	Badalona	Barcelona	Spain	08916
60	Hospital Parc de Salut del Mar /ID# 226696	Barcelona		Spain	08003
61	Hospital Clinic de Barcelona /ID# 226695	Barcelona		Spain	08036
62	Centro Sanitario Sandoval /ID# 226954	Madrid		Spain	28010
63	Hospital General Universitario de Valencia /ID# 226709	Valencia		Spain	46014