CompletedNot Applicable

Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy

Japan344 participantsStarted 2018-01-01

Plain-language summary

An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients who are initiating the treatment with DCV Trio therapy under the approved indications, dosage, and administration Exclusion Criteria: * Patients who use the DCV Trio off label

What they're measuring

Incidence of Aspartate Aminotransferase (AST) elevation

Timeframe: Up to 36 weeks

Incidence of Alanine Aminotransferase (ALT) elevation

Timeframe: Up to 36 weeks

Incidence of Total Bilirubin (tBili) elevation

Timeframe: Up to 36 weeks

Trial details

NCT IDNCT03071133

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-01-08

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