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Safety and efficacy of Glecaprevir / Pibrentasvir combination therapy for chronic hepatitis C - including hemodialysis patients -

Safety and efficacy of Glecaprevir / Pibrentasvir combination therapy for chronic hepatitis C - including hemodialysis patients - - Safety and efficacy of Glecaprevir / Pibrentasvir combination therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032073
Enrollment
1500
Registered
2018-04-03
Start date
2018-01-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with chronic hepatitis C patients and patients with type C compensated cirrhosis

Interventions

Case of chronic hepatitis C of genotype 1 or genotype 2: Three tablets once daily (300 mg as Glecaprevir and 120 mg as Pibrentasvir), orally administered after meals. The administration period is 8 w

Sponsors

Nippon Medical School Chiba Hokusoh Hospital
Lead Sponsor
National Hospital Organization Kyushu Medical Center St. Marianna University School of Medicine Shinmatusdo Central General Hospital Nippon Medical School Nippon Medical School Musashi Kosugi Hospital Otakanomori Hospital Tokyo Metropolitan Bokutoh Hospital Kitasato University School of Medicine Takamatsu Red Cross Hospital Ogaki Municipal Hospital Kagawa Prefectural Central Hospital Kikkoman General Hospital Tokyo Medical University Ibaraki Medical Center Osaka Medical College Na
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who treated with Glecaprevir and Pibrentasvir combination therapy.

Exclusion criteria

Exclusion criteria: 1.History of allergy to Glecaprevir / Pibrentasvir 2.Severe liver dysfunction 3.pregnant woman or lactating mother 4.Hepatocellular carcinoma, or other malignant tumor. 5.severe depression 6.Judged by investigator not to be appropriate for inclusion in this study 7.Receiving contraindicated drugs for Glecaprevir and Pibrentasvir combined therapy

Design outcomes

Primary

MeasureTime frame
SVR 12 rate

Secondary

MeasureTime frame
1. Change in serum HCV RNA during treatment and follow-up duration 2. Change in hematological and biochemical test during treatment and follow-up duration 3. Change in Mac-2 Binding Protein,hyaluronic acid, type IV collagen,gamma globulin during treatment and follow-up duration. 4. Drug concentration after administration in hemodialysis patients.

Countries

Japan

Contacts

Public ContactMasanori Atsukawa

Nippon Medical School Chiba Hokusoh Hospital Division of Gastroenterology

atsukawa-nms@umin.ac.jp0476991111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026