Efficacy Study Of Oral Glecaprevir/Pibrentasvir Tablet In Pediatric (12 Years and Older) And Adult Treatment-Naive Participants With Chronic Hepatitis C Genotypes 1 To 6 And Liver Cirrhosis

NCT04352309 | Completed

• 1 other identifier: P20-276
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 6

Brief Summary

Hepatitis C Virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver) and liver cancer leaving trial participants with need for liver transplant. The purpose of this study is to see how effective Glecaprevir/Pibrentasvir (GLE/PIB) is in a real world setting of participants with chronic HCV genotypes 1 to 6 and liver cirrhosis who have never received any treatment for HCV. GLE/PIB is a drug developed for the treatment of HCV infection. This is a prospective (future), observational study in treatment-naive (those who have not received treatment) participants with HCV genotypes 1 to 6 and compensated cirrhosis. All study participants will receive GLE/PIB as prescribed by their study doctor in accordance with approved local label. Pediatric (12 years and older) and adult participants with a diagnosis of HCV genotypes 1 to 6 and compensated cirrhosis will be enrolled in the study in Russian Federation. Participants will receive GLE/PIB tablets to be taken by mouth daily according to their physicians' prescription. The total duration of the study is 20 weeks, with a treatment period of 8 weeks and a follow up period of 12 weeks. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 12 weeks.

Conditions

Hepatitis C Virus (HCV)

Keywords

HCV, Hepatitis C Virus; Hepatitis C; Liver Cirrhosis; GLE/PIB

Outcome Measures

Primary Outcomes (1)

• Percentage Of Participants Achieving Sustained Virologic Response At 12 Weeks (SVR12)

  SVR12 is defined as Hepatitis C Virus (HCV) RNA \< 50 IU/ml or \< lower limit of quantification/detection (LLoQ/D) available at the site 12 weeks (i.e.,\>=70 days) after the last actual dose.

  At Week 20

Secondary Outcomes (7)

• Number Of Participants Achieving SVR12 After Last Actual Dose Of GLE/PIB At 12 Weeks In Subgroups Of Interest

  At Week 20

• Number Of Participants With Co-morbidities

  At Week 20

• Number Of Participants Taking Concomitant Medication

  At Week 20

• Percentage Of GLE/PIB Dose Taken In Relation To The Prescribed Target Dose

  At Week 20

• Number of Participants With Adverse Events

  Baseline (Week 0) To 30 days post last dose

Study Arms (1)

Participants Treated With Glecaprevir/Pibrentasvir (GLE/PIB)

Participants will receive GLE/PIB over 8 weeks of therapy as prescribed by their physicians.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Treatment-naive Pediatric (12 years and older) and adult participants with confirmed Chronic Hepatitis C (CHC), genotypes 1, 2, 3, 4, 5, or 6 with compensated cirrhosis, being treated with oral Glecaprevir/Pibrentasvir (GLE/PIB) according to standard of care, international guidelines and in line with the current local label.

You may qualify if:

• Treatment-naïve male or female with confirmed CHC, genotypes 1, 2, 3, 4, 5, or 6, with compensated liver cirrhosis, receiving combination therapy with the all oral GLE/PIB regimen for 8 weeks according to standard of care, international guidelines and in line with the current local label.
• Participants may be enrolled up to 4 weeks after treatment initiation.

You may not qualify if:

• Participating or intending to participate in a concurrent interventional therapeutic trial.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (6)

South Ural State Medical University /ID# 225501

Chelyabinsk, 454052, Russia

Location

Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 225499

Irkutsk, 664035, Russia

Location

S. P. Botkin City Hospital /ID# 225500

Oryol, 302038, Russia

Location

Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 222582

Samara, 443029, Russia

Location

Stavropol State Medical University /ID# 226589

Stavropol, 355017, Russia

Location

Medical center Academy /ID# 226587

Ulyanovsk, 432063, Russia

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Hepatitis C; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 20, 2020
• Study Start: May 29, 2020
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: June 9, 2022

Record last verified: 2022-06

Locations

RU (6)