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Evaluation of the Efficacy, Safety, and Pharmacoeconomic Impact of Direct Antiviral Therapy for Genotype 1 Chronic Hepatitis C: A Multicenter Real-World Study.

Evaluation of the Efficacy, Safety, and Pharmacoeconomic Impact of Direct Antiviral Therapy for Genotype 1 Chronic Hepatitis C: A Multicenter Real-World Study.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125052
Enrollment
Unknown
Registered
2026-05-20
Start date
2026-05-20
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

chronic hepatitis C

Interventions

Sofosbuvir and velpatasvir group (retrospective study part):None
Clopavir hydrochloride/sofosbuvir group (retrospective study part):None
Emitasvir phosphate/sofosbuvir group (prospective study part):None
Sofosbuvir and velpatasvir group (prospective study part):None
Clopavir hydrochloride/sofosbuvir group (prospective study part):None

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. All study participants must meet the following criteria: (1) Age >=18 years, regardless of gender; (2) Positive for HCV antibodies, and the disease course has lasted at least 6 months; (3) Detectable serum HCV RNA; (4) HCV genotype 1. 2. Prospective study section: must meet the following criteria: (1) Intending to receive standard antiviral treatment with sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, or glecaprevir/pibrentasvir. (2) Able to understand and willing to comply with the clinical trial protocol requirements, and voluntarily sign written informed consent. 3. Retrospective study section: must meet the following criteria: (1) Have complete medical records, with baseline, end-of-treatment, and 12-week post-treatment records available. (2) Have relatively complete information on direct medical costs incurred during treatment.

Exclusion criteria

Exclusion criteria: 1. Lack of basic demographic and clinical characteristics; 2. Non-genotype 1 individuals; 3. Participation in other drug clinical trials for HCV treatment within three months; 4. Missing data and not meeting basic statistical analysis requirements; 5. Previously received direct antiviral treatment; 6. Participants deemed unsuitable by the investigator

Design outcomes

Primary

MeasureTime frame
High-precision HCV RNA;direct economic cost;

Secondary

MeasureTime frame
adverse reactions;Combination therapy;

Countries

China

Contacts

Public ContactLang Bai

West China Hospital of Sichuan University

pangbailang@163.com+86 28 8542 4838

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026