Study identification

EU PAS number

EUPAS13832

Study ID

33238

Official title and acronym

Evaluation of the potential for and clinical impact of increased ALT in patients using the AbbVie 2-DAA or 3-DAA Regimens in a real world setting

DARWIN EU® study

No

Study countries

Canada
Germany
Israel
United States

Study description

A prospective, observational cohort study of patients with HCV treated with AbbVie 2-DAA or 3-DAA regimens and enrolled in the HCV-TARGET disease registry. This design allows the determination of the differences in clinical outcomes related to hepatotoxicity between patients with and without ALT elevations, identification of associated risk factors, and assessment of the clinical impact of these elevations. The longitudinal design allows for the examination of the clinical impact on treatment course and explores potential risk factors for clinical events of interest. Patients are to be followed for SVR12, potential relapse, and the clinical outcomes of interest for 6 months after the end of treatment. Anonymized patient records from the registry will be the cohort source. Enrollment will begin upon protocol approval and include data retrospectively compiled from patients who were treated with the AbbVie regimens since Jan2015, until the required sample size is reached, approx. Oct2019.

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 61 centres are involved in the study

Networks

HCV-TARGET: Hepatitis C Therapeutic Registry and Research Network

Contact details

Clinical Trial Disclosure AbbVie

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AbbVie
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)