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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02292706
Registration number
NCT02292706
Ethics application status
Date submitted
13/11/2014
Date registered
17/11/2014
Titles & IDs
Public title
A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
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Scientific title
A Registry for Subjects With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
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Secondary ID [1]
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2014-001249-26
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Secondary ID [2]
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GS-US-337-1431
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus Infection
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Condition category
Condition code
Infection
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0
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Studies of infection and infectious agents
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Infection
0
0
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0
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Other infectious diseases
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Infection
0
0
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0
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Sexually transmitted infections
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Oral and Gastrointestinal
0
0
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
0
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0
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Sofosbuvir
Treatment: Drugs - LDV/SOF
Treatment: Drugs - SOF/VEL
Treatment: Drugs - SOF/VEL/VOX
Treatment: Drugs - Other SOF-Based Regimen
Other interventions - Ineligible parent treatment
SOF+RBV - Participants who were previously treated with sofosbuvir (SOF) along with ribavirin (RBV) will be followed up to 5 years.
LDV/SOF - Participants who were previously treated with ledipasvir/sofosbuvir (LDV/SOF) will be followed up to 5 years.
LDV/SOF+RBV - Participants who were previously treated with LDV/SOF along with ribavirin will be followed up to 5 years.
SOF/VEL - Participants who were previously treated with sofosbuvir/velpatasvir (SOF/VEL) will be followed up to 5 years.
SOF/VEL+RBV - Participants who were previously treated with SOF/VEL along with RBV will be followed up to 5 years.
SOF/VEL/VOX - Participants who were previously treated with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) with or without RBV will be followed up to 5 years.
Other SOF-Based - Participants who previously received other SOF based regimen will be followed up to 5 years.
Enrolled From Ineligible Parent Treatment Group - Participants were enrolled from ineligible parent treatment group.
Treatment: Drugs: Sofosbuvir
Exposure of interest for participants who received sofosbuvir in a previous Gilead study for chronic HCV infection.
Treatment: Drugs: LDV/SOF
Exposure of interest for participants who received LDV/SOF in a previous Gilead study for chronic HCV infection.
Treatment: Drugs: SOF/VEL
Exposure of interest for participants who received SOF/VEL in a previous Gilead study for chronic HCV infection.
Treatment: Drugs: SOF/VEL/VOX
Exposure of interest for participants who received SOF/VEL/VOX in a previous Gilead study for chronic HCV infection.
Treatment: Drugs: Other SOF-Based Regimen
The other SOF-based regimens may have included the following:
* BMS-790052 (Daclatasvir) + GS-7977 (SOF) with or without RBV
* LDV/SOF + GS-9669, GS-7977 (SOF) + with or without RBV + TMC-435 (Simeprevir)
* LDV/SOF + Vedroprevir (VDV), LDV/SOF + GS-9669 (250 mg and 500 mg)
* LDV/SOF + VDV + RBV
* Simeprevir + SOF
* TMC-435 (Simeprevir) + VEL/SOF
Other interventions: Ineligible parent treatment
Participants were enrolled from ineligible parent treatment group.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240
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Assessment method [1]
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SVR at Week 240 was defined as HCV RNA\< lower limit of quantification (LLOQ i.e., 15 or 25 international units per milliliter \[IU/mL\]) or last available HCV RNA\< LLOQ with no subsequent follow-up values at Week 240 after enrollment in this registry study. Percentage of participants who maintained SVR status by Week 240 was estimated using a Kaplan-Meier model.
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Timepoint [1]
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Week 240
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Primary outcome [2]
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Percentage of Participants With Any Liver-Associated Events
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Assessment method [2]
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The percentage of participants with any liver-associated events since registry start (enrollment) through Week 240 was estimated using a Kaplan-Meier model.
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Timepoint [2]
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Enrollment up to 240 weeks
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Primary outcome [3]
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Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240
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Assessment method [3]
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Participants with de novo HCC since registry start were defined as participants who had not been identified with HCC prior to registry start and only had HCC since registry start. The percentage of participants who developed de novo HCC through Week 240 was estimated using a Kaplan-Meier model.
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Timepoint [3]
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Enrollment up to 240 weeks
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Secondary outcome [1]
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Number of Participants With Detectable HCV RNA Due to Re-emergence of Pre-existing Virus Through Week 240
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Assessment method [1]
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Timepoint [1]
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Enrollment up to 240 weeks
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Secondary outcome [2]
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Number of Participants With Detectable HCV Resistance Mutations Through Week 240
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Assessment method [2]
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Timepoint [2]
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Enrollment up to 240 weeks
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Secondary outcome [3]
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Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240
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Assessment method [3]
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Reinfection was defined as HCV RNA \> LLOQ on 2 samples collected at least 1 week apart with a different virus than that present prior to treatment baseline in the parent study.
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Timepoint [3]
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Enrollment up to 240 weeks
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Eligibility
Key inclusion criteria
Key
* Willing and able to provide written informed consent
* Have either previously participated in a Gilead-sponsored HCV study and received a sofosbuvir-containing regimen without interferon OR at pre-selected sites only, have received an all-oral SOF-based regimen outside a clinical study. These individuals must have documentation of the regimen, start and end of treatment dates (month and year), and of having achieved SVR12.
* Have achieved SVR either in a Gilead-sponsored study, as defined in the treatment protocol OR for individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, SVR will be defined as HCV RNA < lower limit of quantification (LLOQ) approximately 12 weeks following last dose of treatment.
* Have liver cirrhosis, as defined in the treatment protocol, and have not had a liver transplant after receiving a SOF-containing regimen OR individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, will have had cirrhosis confirmed prior to initiation of HCV treatment.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Individuals planning to initiate a new course of HCV therapy, including approved products and any investigational agents, during the course of this Registry
* History of clinically-significant illness or any other major medical disorder that may interfere with the follow-up, assessments, or compliance with the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/12/2014
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Date of last participant enrolment
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Actual
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Date of last data collection
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Actual
31/12/2021
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Sample size
Target
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Accrual to date
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Final
1609
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Royal Prince Alfred Hospital - Camperdown
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Kirby Institute - Sydney
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Westmead Hospital - Westmead
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Royal Brisbane & Women's Hospital - Herston
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Austin Health - Heidelberg
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Monash Medical Centre Clayton Campus - Melbourne
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Fiona Stanley Hospital - Fremantle
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3084 - Heidelberg
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- Perth
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Portsmouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Ethics approval
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Summary
Brief summary
The primary objective of this registry study is to assess the durability of sustained virologic response (SVR) and clinical progression or regression of liver disease including the incidence of hepatocellular carcinoma following SVR in participants with cirrhosis after treatment with a sofosbuvir-based regimen for HCV infection.
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Trial website
https://clinicaltrials.gov/study/NCT02292706
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Trial related presentations / publications
Dunn W, Koestler D, Ni L, Kersey K, Kreter B, Hammond K et al. Cirrhosis regression based on both Enhanced Liver Fibrosis (ELF) and Fibrotest after Direct-acting Hepatitis C therapeutics corresponds to a lower incidence rate of hepatocellular carcinoma below the cost-effective threshold for surveillance [Poster 1289]. The International Liver Congress™ EASL - European Association for the Study of the Liver (EASL); 2021 23-26 June. Fan R, Papatheodoridis G, Sun J, Innes H, Toyoda H, Xie Q, Mo S, Sypsa V, Guha IN, Kumada T, Niu J, Dalekos G, Yasuda S, Barnes E, Lian J, Suri V, Idilman R, Barclay ST, Dou X, Berg T, Hayes PC, Flaherty JF, Zhou Y, Zhang Z, Buti M, Hutchinson SJ, Guo Y, Calleja JL, Lin L, Zhao L, Chen Y, Janssen HLA, Zhu C, Shi L, Tang X, Gaggar A, Wei L, Jia J, Irving WL, Johnson PJ, Lampertico P, Hou J. aMAP risk score predicts hepatocellular carcinoma development in patients with chronic hepatitis. J Hepatol. 2020 Dec;73(6):1368-1378. doi: 10.1016/j.jhep.2020.07.025. Epub 2020 Jul 21. Jacobson I, Muir AJ, Lawitz EJ, Gane E, Conway B, Ruane PJ, et al. Course of Cirrhosis Regression: Lessons From Patients With HCV Cirrhosis Following Successful Sofosbuvir-Based Treatment [Poster 537]. AASLD: The Liver Meeting® 2019, November 11-15. Mangia A, Lawitz E, Gane E Conway B, Ruane PJ, Abergel A, et al. Long-Term Follow-up of Patients with Chronic HCV Infection and Compensated or Decompensated Cirrhosis Following Treatment with Sofosbuvir-Based Regimens. The International Liver Congress™ EASL - European Association for the Study of the Liver (EASL); 2018 April 11-15. Muir AJ, Buti M, Nahass R, Agarwal K, Gane EJ, Strasser SI, et al. Long-term Follow-up of Patients With Chronic HCV Infection and Compensated or Decompensated Cirrhosis Following Treatment With Sofosbuvir-Based Regimens [Poster 880]. AASLD: The Liver Meeting® 2019, November 11-15. Reddy KR, Bourlière M, Agarwal K, Lawitz E, Osinusi A, Kersey K, et al. Sustained Viral Response Following Treatment With Direct-Acting Antiviral Agents for Chronic Hepatitis C and the Risk of Hepatocellular Carcinoma [Poster FRI-185]. The International Liver Congress™ EASL - European Association for the Study of the Liver (EASL); 2017 19-23 April. Reddy R, Muir A, Naggie S, Lawitz E, Gane E, Conway B et al. Noninvasive Tests of Fibrosis and Risk of Liver-Related Complications: Lessons From Patients With HCV Cirrhosis Following Successful Sofosbuvir-Based Treatment [Poster 452]. The International Liver Congress™ EASL - European Association for the Study of the Liver (EASL); 2020 27-29 August. Reddy R, Muir A, Naggie S, Lawitz E, Gane E, Conway B et al. Non-invasive tests of fibrosis and risk of liver-related complications: observations following successful sofosbuvir-based treatment in patients with HCV cirrhosis. J Hepatology 2020;73: S401-S652. Younossi ZM, Racila A, Muir A, Bourliere M, Mangia A, Esteban R, Zeuzem S, Colombo M, Manns M, Papatheodoridis GV, Buti M, Chokkalingam A, Gaggar A, Nader F, Younossi I, Henry L, Stepanova M. Long-term Patient-Centered Outcomes in Cirrhotic Patients With Chronic Hepatitis C After Achieving Sustained Virologic Response. Clin Gastroenterol Hepatol. 2022 Feb;20(2):438-446. doi: 10.1016/j.cgh.2021.01.026. Epub 2021 Jan 22.
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Public notes
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Contacts
Principal investigator
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Gilead Study Director
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Gilead Sciences
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
18 months after study completion
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Available to whom?
A secured external environment with username, password, and RSA code.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.gileadclinicaltrials.com/transparency-policy/
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/06/NCT02292706/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/06/NCT02292706/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02292706