Efficacy and Safety of 8-weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1

Hepatitis C Virus (HCV) Clinical Trial

Official title:

A Single Arm, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotypes 1 - 6 Infection and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤ 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212521
• Other study ID #: M16-133
• Secondary ID: 2016-004876-23
• Status: Completed
• Phase: Phase 3
• Start date: August 7, 2017
• Est. completion date: August 13, 2018

Study information

• Verified date: August 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: August 13, 2018
• Est. primary completion date: August 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection. Mixed GT and indeterminate GT may be acceptable.

• Aspartate aminotransferase (AST) to platelet ratio index (APRI) score of less than or equal to 1, at time of screening.

• Does not have current active hepatitis B virus infection defined as:

• positive hepatitis B surface antigen (HBsAg), OR

• hepatitis B virus (HBV) deoxyribonucleic acid (DNA) > lower limit of quantification (LLOQ) in subjects with isolated positive anti-hepatitis B core (HBc) (i.e., negative HBsAg and anti-hepatitis B surface[HBs])

• Platelets = 150,000 cells/mm³

• Albumin = lower limit of normal (LLN)

• Positive anti-HCV antibody (Ab) AND plasma HCV ribonucleic acid (RNA) viral load = 1,000 IU/mL at Screening and for at least 6 months before Screening.

• No past history/evidence of cirrhosis.

• No history of hepatocellular carcinoma.

• Hepatitis C virus treatment-naïve (had not received a single dose of any approved or investigational anti-HCV medication).

• If female, the subject must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus (HCV)

Intervention

Drug:
• Glecaprevir/Pibrentasvir
Glecaprevir/pibrentasvir 100 mg/40 mg co-formulated tablets taken orally as 3 tablets once a day.

Locations

Country	Name	City	State
Bulgaria	DCC Aleksandrovska /ID# 161340	?????	Sofia
Bulgaria	DCC Mladost M /ID# 161339	Varna
Canada	Brampton Civic Hospital /ID# 161380	Brampton	Ontario
Canada	South Health Campus /ID# 161385	Calgary	Alberta
Canada	The Moncton Hospital /ID# 161384	Moncton	New Brunswick
Canada	Toronto Liver Centre /ID# 161381	Toronto	Ontario
France	CHU de Besancon - Jean Minjoz /ID# 161485	Besancon	Doubs
France	Hopital Saint Joseph /ID# 161571	Marseille CEDEX 08	Bouches-du-Rhone
France	CHU de Rennes - PONTCHAILLOU /ID# 161492	Rennes	Bretagne
France	Hopitaux de Brabois Adultes /ID# 161482	Vandoeuvre les Nancy	Lorraine
Germany	Charité Universitätsmedizin Campus Mitte /ID# 161395	Berlin
Germany	Universitätsklinikum Frankfurt /ID# 161397	Frankfurt am Main	Hessen
Germany	ICH Study Center GmbH & Co KG /ID# 161394	Hamburg
Germany	Universitaetsmedizin der Johannes-Gutenberg Universität Mainz /ID# 161396	Mainz	Rheinland-Pfalz
Poland	Uniwersytecki Szpital Kliniczn /ID# 162216	Bialystok
Poland	HepID - Diagnostyka I Terapia /ID# 162219	Lublin	Lubelskie
Poland	ID Clinic /ID# 162217	Myslowice
Poland	Centrum Badan Klinicznych /Id# 162218	Wroclaw	Dolnoslaskie
Puerto Rico	Innovative Care P.S.C. /ID# 162787	San Juan
Russian Federation	South Ural State Medical univ /ID# 163163	Chelyabinsk
Russian Federation	A. F. Agafonov Republican Clin /ID# 163164	Kazan	Tatarstan, Respublika
Russian Federation	A.I. Evdokimov Moscow State Un /ID# 163162	Moscow
Spain	Hospital Fundacion Alcorcon /ID# 161436	Alcorcon
Spain	Hospital Clinic de Barcelona /ID# 161437	Barcelona
Spain	Hospital Vall d'Hebron /ID# 162022	Barcelona
Spain	Hosp Uni Virgen de la Victoria /ID# 164383	Malaga
Spain	Complexo Hospitalario universi /ID# 165603	Pontevedra
United Kingdom	Bradford Teaching Hospitals /ID# 161424	Bradford
United Kingdom	Glasgow Royal Infirmary /ID# 161458	Glasgow
United Kingdom	Gloucester Royal Hospital /ID# 161423	Gloucester
United Kingdom	Freeman Hospital /ID# 161459	Newcastle Upon Tyne
United States	University of Michigan Hospitals /ID# 161265	Ann Arbor	Michigan
United States	Digestive Disease Associates - Baltimore /ID# 161260	Baltimore	Maryland
United States	Univ Maryland School Medicine /ID# 161157	Baltimore	Maryland
United States	Parkway Medical Center /ID# 161261	Birmingham	Alabama
United States	University of Vermont Medical Center /ID# 161263	Burlington	Vermont
United States	Liver Associates of Texas, P.A /ID# 161262	Houston	Texas
United States	Yale University /ID# 161258	New Haven	Connecticut
United States	Digestive and Liver Disease Sp /ID# 161259	Norfolk	Virginia
United States	Arkansas Gastroenterology /ID# 161266	North Little Rock	Arkansas
United States	Northwest Gastroenterology Cli /ID# 161257	Portland	Oregon
United States	UC Davis Medical Center /ID# 161138	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  France,  Germany,  Poland,  Puerto Rico,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants in the Modified Intention-to-Treat Population With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.; The 95% confidence interval (95%CI) was calculated using the Wilson's score method.; Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 92.4%, based on the historical rate observed in glecaprevir/pibrentasvir registrational studies in treatment-naïve, non-cirrhotic patients (98.4%) minus a margin of 6%.	12 weeks after the last actual dose of study drug, Week 20
Secondary	Percentage of Participants in the Intention-to-Treat Population With SVR12	SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the LLOQ (15 IU/mL) 12 weeks after the last dose of study drug.; The 95% confidence interval was calculated using the normal approximation to the binomial distribution. Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 91.4%, based on the mITT threshold minus an expected 1% rate of non-virological SVR failures.	12 weeks after the last actual dose of study drug, Week 20
Secondary	Percentage of Participants With On-treatment Virologic Failure	On-treatment virologic failure was defined as one of the following conditions: confirmed HCV RNA = 100 IU/mL after HCV RNA < 15 IU/mL during the Treatment Period; or; confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) at any time point during the Treatment Period; or; HCV RNA = 15 IU/mL at end of treatment with at least 6 weeks of treatment, where the HCV RNA value must be collected on or after Study Drug Day 36 and study drug duration = 36 days.	Up to 8 weeks
Secondary	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 with HCV RNA levels < LLOQ at the end of treatment.	From the end of treatment (Week 8) through 12 weeks after the last dose of study drug (Week 20)