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

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ClinicalTrials.gov Identifier: NCT03071133
Recruitment Status : Recruiting
First Posted : March 6, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease
Hepatitis C

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Asunaprevir/Daclatasvir/Beclabuvir Fixed-Dose Combination Safety Surveillance in Japanese Patients With Chronic Hepatitis C (HCV) or Japanese Patients With Compensated Cirrhosis
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : November 20, 2019
Estimated Study Completion Date : November 20, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Incidence of Aspartate Aminotransferase (AST) elevation [ Time Frame: Up to 36 weeks ]
    measured by immunoassay

  2. Incidence of Alanine Aminotransferase (ALT) elevation [ Time Frame: Up to 36 weeks ]
    measured by immunoassay

  3. Incidence of Total Bilirubin (tBili) elevation [ Time Frame: Up to 36 weeks ]
    measured by immunoassay


Secondary Outcome Measures :
  1. Incidence of adverse drug reactions (ADRs) in HCV patients treated with DCV Trio therapy in Japan [ Time Frame: Up to 36 weeks ]
    measured by adverse events

  2. Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) [ Time Frame: Up to 24 weeks ]
    measured by number of patients

  3. Proportion of patients with undetectable HCV RNA at 24 weeks post-treatment (SVR24) [ Time Frame: Up to 36 weeks ]
    measured by number of patients

  4. Percentage of patients to experience virologic breakthrough [ Time Frame: Up to 36 weeks ]
    measured by percentage of patients



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in Japan who are initiating treatment with DCV Trio therapy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071133


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
Japan
Local Institution Recruiting
Tokyo, Japan, 1620814
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03071133     History of Changes
Other Study ID Numbers: AI443-144
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections