Detection and analysis of HCV resistance to new HCV drugs and autologous antibody responses

Detection and analysis of HCV resistance to new HCV drugs and autologous antibody responses - PEPSI-II

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00010889

Enrollment

10000

Registered

2017-02-07

Start date

2016-11-23

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

B18.2 B17.1

Interventions

Group 1: Patients with initial diagnosis of HCV or patients with HCV-therapy failure are included to perform HCV-resistency analysis using molecular biological methods (PCR). Furthermore, blood sera a

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: confirmed replicative HCV-infection; intended start of renewed DAA-therapy; mental capacity; signed informed consent

Exclusion criteria

Exclusion criteria: age < 18 years

Design outcomes

Primary

Measure	Time frame
Identification of HCV resistant mutations before, during and after drug treatment using molecular biological methods like PCR	—

Secondary

Measure	Time frame
up-grate public geno2pheno[hcv] server; correlation between cellular markers and treatment failures; identification of HCV-specific neutralizing antibodies	—

Countries

Germany

Contacts

Public ContactRolf Kaiser

Institut für Virologie, Universität zu Köln

rolf.kaiser@uk-koeln.de+49 221 478 7741

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026