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Direct Acting Antiviral-Post Authorization Safety Study

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ClinicalTrials.gov Identifier: NCT03707080
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Target PharmaSolutions, Inc.

Tracking Information
First Submitted Date October 8, 2018
First Posted Date October 16, 2018
Last Update Posted Date March 14, 2019
Actual Study Start Date March 9, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 12, 2018)
Time to HCC recurrence - Prospective Cohort [ Time Frame: 24 months ]
Time to HCC recurrence associated with DAA therapy relative to no DAA therapy in the prospective cohort.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03707080 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 12, 2018)
  • Number of events of early HCC recurrence - Prospective Cohort [ Time Frame: 24 months ]
    Number of events (early HCC recurrence) associated with DAA therapy relative to no DAA therapy in the prospective cohort.
  • Time to HCC recurrence - Prospective Cohort relative to Historical Cohort [ Time Frame: 24 months ]
    Time to HCC recurrence associated with DAA therapy in the prospective cohort relative to no DAA therapy in the historical cohort.
  • Number of events of early HCC recurrence - Prospective Cohort relative to Historical Cohort [ Time Frame: 24 months ]
    Number of events (early HCC recurrence) associated with DAA therapy in the prospective cohort relative to no DAA therapy in the historical cohort. historical cohort of HCV patients not exposed to DAA with initial HCC diagnosis and subsequent successful treatment of HCC.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Direct Acting Antiviral-Post Authorization Safety Study
Official Title DAA-PASS: A Post-Authorisation Safety Study of Early Recurrence of Hepatocellular Carcinoma in HCV-Infected Patients After Direct-Acting Antiviral Therapy
Brief Summary This is an independent optional sub-study parallel to TARGET-HCC (NCT02954094). The purpose of Direct-Acting Antiviral-Post Authorization Safety Study (DAA-PASS) is to investigate the impact of exposure to direct-acting antivirals (DAAs) on early recurrence of hepatocellular carcinoma (HCC) in hepatitis C virus (HCV)-infected patients following successful HCC treatment interventions.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The prospective DAA-PASS cohort will include a subset of HCV RNA positive participants in the TARGET-HCC study who meet entry criteria including hepatitis C (with no prior history of DAA therapy) and newly diagnosed Barcelona Clinic Liver Cancer (BCLC) Stage A HCC. Approximately 600 participants will be enrolled. Participants will be enrolled in the countries participating in TARGET-HCC which will include: United States (US), France, Germany, Italy, and Spain.
Condition
  • Hepatitis C
  • Hepatocellular Carcinoma
Intervention Not Provided
Study Groups/Cohorts
  • Prospective

    The prospective DAA-PASS cohort will include a subset of HCV RNA positive participants in the TARGET-HCC study who meet entry criteria including hepatitis C (with no prior history of DAA therapy) and newly diagnosed Barcelona Clinic Liver Cancer (BCLC) Stage A HCC.

    Approximately 600 participants will be enrolled. Participants will be enrolled in the countries participating in TARGET-HCC which will include: United States (US), France, Germany, Italy, and Spain.

  • Historical
    The historical cohort will be derived from the ITA.LI.CA database, which includes data on all consecutive patients with HCC who were managed within participating centers in Italy. The historical cohort will include patients from the ITA.LI.CA database who have active HCV infection who were not treated for HCV (IFN-based or DAA-based regimens) during the followup period, with initial HCC diagnosis BCLC Stage A, and subsequent successful treatment of HCC with curative therapy.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 12, 2018)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Screening Inclusion Criteria:

  • Current participant in TARGET-HCC
  • Adults, age ≥18 years
  • First diagnosis of HCC (mixed HCC/cholangiocarcinoma may be included). Diagnosis may be histological/cytological and/or radiological.
  • BCLC Stage A
  • Underwent, undergoing, or planned to undergo therapy for HCC, with exception that transplant as prior or planned treatment for HCC is excluded.
  • HCV RNA positive

Screening Exclusion Criteria:

  • Inability to provide informed consent
  • HCC-free imaging (as defined in Section 9.1.1) after treatment of initial HCC prior to Screening (see Section 9.2.9 for imaging details)
  • Prior liver transplantation
  • Hepatitis B Virus (HBV) surface antigen positive (HBsAg)
  • Previously treated with direct-acting antiviral agents (not DAA-naïve); Note that prior (peg)IFN and/or ribavirin therapy is allowed

Enrollment Inclusion Criteria:

  • Continued participation in TARGET-HCC
  • No recurrence or progression of initial HCC beyond BCLC Stage A prior to Enrollment/Baseline
  • HCC-free imaging (as defined in Section 9.1.1) at Enrollment/Baseline (see Section 9.2.9 for imaging details; participants may remain in Screening until an HCC-free image is obtained)
  • Remains DAA-naïve (prior therapy with (peg)IFN and/or ribavirin is allowed)

Enrollment Exclusion Criteria:

- Liver transplantation since Screening

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mara Grbic, MPH 984-234-0268 mgrbic@targetpharmasolutions.com
Listed Location Countries France,   Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03707080
Other Study ID Numbers TARGET-HCC DAA-PASS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Target PharmaSolutions, Inc.
Study Sponsor Target PharmaSolutions, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Target PharmaSolutions, Inc.
Verification Date October 2018