Study of Oral Glecaprevir/Pibrentasvir Tablets in Participants Aged 12 Years or Older With Chronic Hepatitis C to Assess Sustained Virological Response
- Conditions
- Hepatitis C Virus (HCV)
- Registration Number
- NCT04577482
- Lead Sponsor
- AbbVie
- 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), liver cancer or the need for liver transplant. This study will evaluate how effective glecaprevir/pibrentasvir (GLE/PIB) is in participants with chronic HCV infection. Effectiveness will be assessed as the achievement of sustained virologic response.
GLE/PIB is an approved drug for the treatment of HCV. Participants 12 years or older with chronic HCV infection will be enrolled. This is a prospective (conducted in future) study in therapy of direct-acting antiviral (DAA) treatment-experienced participants with chronic hepatitis C genotype 1. Around 67 participants will be enrolled at multiple sites in Russian Federation.
Participants will receive oral GLE/PIB tablets as prescribed by the physician in accordance with local clinical practice, international guidelines and/or label. Prescription is independent from this study and is decided before providing opportunity to the participate in the study.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Direct-acting antiviral treatment-experienced participants with confirmed chronic hepatitis C (CHC) genotype 1, receiving combination therapy with the all oral glecaprevir/pibrentasvir (GLE/PIB) regimens according to standard of care, international guidelines and in line with the current local label.
- Participants can enroll up to 4 weeks after starting treatment
- Participating or intending to participate in a concurrent interventional therapeutic trial.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Sustained Virological Response (SVR) at Week 12 (SVR12) Week 12 after the end of treatment SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) \< 50 IU/ml or lower limit of quantification/detection (LLoQ/D) available at the site at Week 12 after the last actual dose.
- Secondary Outcome Measures
Name Time Method Percent of Glecaprevir/Pibrentasvir Dose Taken by Participant Report in Relation to the Prescribed Target Dose Up to Week 12 after the end of treatment Number of pills taken out of the number that should have been taken will be calculated.
Number of Participants With Co-morbidities and Taking Concomitant Medication Up to Week 12 after the end of treatment Number of participants with co-morbidities and taking concomitant medication of interest report will be calculated.
Health Care Resource Utilization (HCRU) Up to Week 12 after the end of treatment HCRU will be total number of visits/touchpoints (face to face or phone call) with a Health Care Provider (HCP) or designee in relation to their HCV infection during the study as recorded overall and by subpopulations of interest.
Number of Participants With Adverse Events (AEs) Up to Week 12 after the end of treatment An adverse event (AE) is defined as any untoward medical occurrence in a patient which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug overall and in subgroups of interest. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Percentage of Participants Who Experienced Post-Baseline Shifts in Clinical Laboratory Values Up to Week 12 after the end of treatment Percentage of participants who experience post-baseline shifts during treatment in clinical laboratory values will be summarized overall and in subgroups of interest.
Percentage of Participants Achieving SVR12 Week 12 after the end of treatment SVR12 is defined as HCV RNA \< LLoQ/D 12 weeks after the last actual dose of GLE/PIB with a sensitive polymerase chain reaction (PCR) available in the clinical site in the settings of the Russian Federation in subgroups of interest.
Trial Locations
- Locations (10)
Irkutsk Regional Center for the Prevention and Control of AIDS and Infections /ID# 229509
🇷🇺Irkutsk, Russian Federation
Infectious Clinical Hosp #1 /ID# 225063
🇷🇺Moscow, Russian Federation
Infectious Clinical Hospita l#2 /ID# 243217
🇷🇺Nizhniy Novgorod, Russian Federation
S. P. Botkin City Hospital /ID# 229510
🇷🇺Oryol, Russian Federation
Samara Region Clinical HIV/AIDS Prevention and Control Center /ID# 226591
🇷🇺Samara, Russian Federation
South Ural State Medical University /ID# 226555
🇷🇺Chelyabinsk, Russian Federation
LLC Center of Targeted Therapy /ID# 239529
🇷🇺Domodedovo, Russian Federation
Specialized Clinical Infectious Diseases Hospital /ID# 229814
🇷🇺Krasnodar, Russian Federation
Saint-Petersburg AIDS Center /ID# 239357
🇷🇺St. Petersburg, Russian Federation
Stavropol State Medical University /ID# 243216
🇷🇺Stavropol, Russian Federation