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Examination of virological response and predictive factors in Elbasvir/Grazoprevir combination therapy for genotype1 infected chronic hepatitis C patients

Examination of virological response and predictive factors in Elbasvir/Grazoprevir combination therapy for genotype1 infected chronic hepatitis C patients - Examination of virological response and predictive factors in Elbasvir/Grazoprevir combination therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000029262
Enrollment
300
Registered
2017-09-25
Start date
2017-07-05
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

Chronic hepatitis C

Interventions

Treat with Elbasvir/Grazoprevir combination therapy ERELSA 50mg:one tablet once a day for 12 weeks GRAZYNA 50mg:two tablets once a day for 12 weeks

Sponsors

Nippon Medical School Chiba Hokusoh Hospital
Lead Sponsor
Nippon Medical School Hospital Nippon Medical School Musashi Kosugi Hospital The Jikei University Hospital Otakanomori Hospital Hakujikai Healthcare foundation Tokyo Metropolitan Bokutoh Hospital Tokyo Medical University Ibaraki Medical Center Shinmatsudo Central General Hospital Japanese Red Cross Narita Hospital Nagoya City University Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who treated with Elbasvir/Grazoprevir combination therapy. Patients with chronic hepatits C, genotype 1

Exclusion criteria

Exclusion criteria: 1.History of allergy to Elbasvir/Grazoprevir 2.Decompensated liver cirrhosis 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 Elbasvir/Grazoprevir combined therapy

Design outcomes

Primary

MeasureTime frame
Sustained virological response 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.

Countries

Japan

Contacts

Public ContactTomomi Okubo

Nippon Medical School Chiba Hokusoh Hospital Division of Gastroenterology

ma6-0154@nms.ac.jp0476991111

Outcome results

None listed

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