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German Hepatitis C-Registry (DHC-R)

German Hepatitis C-Registry (DHC-R) - DHC-R

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00009717
Enrollment
20000
Registered
2015-11-30
Start date
2014-11-24
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

B18.2

Interventions

Group 1: Treatment of patients with cronic hepatitis c infection. Documentation of parameters from standard diagnostics, quality of life questionnaire (SF36) and (serious) adverse events.

Sponsors

Leberstiftungs-GmbH Deutschland
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age 18 and chronic Hepatitis C Virus infection with viral replication (HCV-RNA +) Patients which are treated with the following antiviral therapies can be documented in the registry: elbasvir/grazoprevir (up to 3,000 patients); glecaprevir/pibrentasvir (up to 800 patients with active drug abuse and/or alcohol abuse and/or compensated liver cirrhosis (Child-Pugh A)); sofosbuvir/velpatasvir/voxilaprevir (exclusively as rescue therapy after DAA failure, up to 300 patients) Moreover, patients which are not treated can be documented in the registry. Patients are treated at the sole discretion of the physician.

Exclusion criteria

Exclusion criteria: Pregnancy (patient or female partner of male patient), women in nursing period or women of childbearing age without reliable contraception. Contraindications for use of antiviral treatment. Treatment of hepatitis c, which is conducted in clinial trials of phase I to IV must not be documented in the DHC-R. Patients whose hepatitis c treatment is documented in other remunerated non-interventional studies are not allowed to be documented simultaneously in the DHC-R.

Design outcomes

Primary

MeasureTime frame
Proportion of patients, who achieved sustained virological response 12 weeks after end of treatement (SVR12).

Secondary

MeasureTime frame
Safety & tolerability: all (severe) adverse events during treatment and follow-up period). virological outcome: RVR, EVR, EoTR, SVR24, on-treatment failure, viral relapse rates. Baseline including: Cirrhosis, previous therapy (if applicable), IL28B GT, BMI, Race, Age, viral genotype and viral load, rel-evant laboratory parameters, concomitant diseases. Adherence to therapy. Impact of successful therapy on morbidity and mortality on patients. Patient reported outcomes (based on patient questionnaires and clinical outcomes).

Countries

Germany

Contacts

Public ContactYvonne Serfert

Leberstiftungs-GmbH Deutschland

info@leberstiftungs-gmbh.de05115326968

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 1, 2026