Predictive factors associated with virological response in Daclatasvir and Asunaprevir combination therapy for genotype1b-infected chronic hepatitis C patients : multicenter study

Predictive factors associated with virological response in Daclatasvir and Asunaprevir combination therapy for genotype1b-infected chronic hepatitis C patients : multicenter study - Predictive factors for virological response in Daclatasvir and Asunaprevir combination therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017149

Enrollment

300

Registered

2015-04-17

Start date

2015-04-17

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

Patients were treated with Daclatasvir and Asunaprevir combination therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with chronic hepatitis C who treat with Daclatasvir/Asunaprevir combination therapy.

Exclusion criteria

Exclusion criteria: 1.History of allergy to Daclatasvir, and Asunaprevir. 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

Design outcomes

Primary

Measure	Time frame
Sustained virological response rate	—

Secondary

Measure	Time 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 beta-hydroxycholesterol during treatment and follow-up duration 4. Safety and efficacy of treatment for patients with renal insufficiency or renal failure including hemodyalysis 5. Change in Mac-2 Binding Protein,hyaluronic acid, type IV collagen,gamma globulin during treatment and follow-up duration.	—

Measure

Time 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 beta-hydroxycholesterol during treatment and follow-up duration 4. Safety and efficacy of treatment for patients with renal insufficiency or renal failure including hemodyalysis 5. Change in Mac-2 Binding Protein,hyaluronic acid, type IV collagen,gamma globulin during treatment and follow-up duration.

—

Countries

Japan

Contacts

Public ContactMasanori Atsukawa

Nippon Medical School Chiba Hokusoh Hospital Division of Gastroenterology

atsukawa-nms@umin.ac.jp0476-99-1111

Outcome results

None listed

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