Direct Acting Antiviral-Post Authorization Safety Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03707080 |
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Recruitment Status :
Active, not recruiting
First Posted : October 16, 2018
Last Update Posted : January 12, 2021
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| Condition or disease |
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| Hepatitis C Hepatocellular Carcinoma |
| Study Type : | Observational |
| Estimated Enrollment : | 70 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Official Title: | DAA-PASS: A Post-Authorisation Safety Study of Early Recurrence of Hepatocellular Carcinoma in HCV-Infected Patients After Direct-Acting Antiviral Therapy |
| Actual Study Start Date : | March 9, 2018 |
| Estimated Primary Completion Date : | June 30, 2021 |
| Estimated Study Completion Date : | June 30, 2021 |
| Group/Cohort |
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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. Participants will be enrolled in the countries participating in TARGET-HCC which will include: United States (US), France, Germany, Italy, and Spain. |
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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.
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- Time to HCC recurrence - Prospective Cohort [ Time Frame: up to 24 months ]Time to HCC recurrence associated with DAA therapy relative to no DAA therapy in the prospective cohort.
- Number of events of early HCC recurrence - Prospective Cohort [ Time Frame: up to 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: up to 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: up to 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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): NCT03707080
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| Responsible Party: | Target PharmaSolutions, Inc. |
| ClinicalTrials.gov Identifier: | NCT03707080 |
| Other Study ID Numbers: |
TARGET-HCC DAA-PASS |
| First Posted: | October 16, 2018 Key Record Dates |
| Last Update Posted: | January 12, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Hepatitis C Hepatitis Hepatitis, Viral, Human Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Liver Diseases |
Digestive System Diseases Virus Diseases Flaviviridae Infections RNA Virus Infections Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |