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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02292706




Registration number
NCT02292706
Ethics application status
Date submitted
13/11/2014
Date registered
17/11/2014
Date last updated
4/10/2023

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
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
Secondary ID [1] 0 0
2014-001249-26
Secondary ID [2] 0 0
GS-US-337-1431
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Sofosbuvir
Treatment: Drugs - Ribavirin
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: Ribavirin


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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240
Timepoint [1] 0 0
Week 240
Primary outcome [2] 0 0
Percentage of Participants With Any Liver-Associated Events
Timepoint [2] 0 0
Enrollment up to 240 weeks
Primary outcome [3] 0 0
Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240
Timepoint [3] 0 0
Enrollment up to 240 weeks
Secondary outcome [1] 0 0
Number of Participants With Detectable HCV RNA Due to Re-emergence of Pre-existing Virus Through Week 240
Timepoint [1] 0 0
Enrollment up to 240 weeks
Secondary outcome [2] 0 0
Number of Participants With Detectable HCV Resistance Mutations Through Week 240
Timepoint [2] 0 0
Enrollment up to 240 weeks
Secondary outcome [3] 0 0
Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240
Timepoint [3] 0 0
Enrollment up to 240 weeks

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.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2021
Sample size
Target
Accrual to date
Final
1609
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Kirby Institute - Sydney
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
St Vincents Hospital Sydney - Fitzroy
Recruitment hospital [7] 0 0
Austin Health - Heidelberg
Recruitment hospital [8] 0 0
Monash Medical Centre Clayton Campus - Melbourne
Recruitment hospital [9] 0 0
The Alfred Hospital - Prahran
Recruitment hospital [10] 0 0
Fiona Stanley Hospital - Fremantle
Recruitment hospital [11] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment postcode(s) [4] 0 0
- Herston
Recruitment postcode(s) [5] 0 0
- Woolloongabba
Recruitment postcode(s) [6] 0 0
- Fitzroy
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
- Melbourne
Recruitment postcode(s) [9] 0 0
- Prahran
Recruitment postcode(s) [10] 0 0
- Fremantle
Recruitment postcode(s) [11] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New Mexico
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
Rhode Island
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Utah
Country [26] 0 0
United States of America
State/province [26] 0 0
Virginia
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
Canada
State/province [28] 0 0
Alberta
Country [29] 0 0
Canada
State/province [29] 0 0
British Columbia
Country [30] 0 0
Canada
State/province [30] 0 0
Ontario
Country [31] 0 0
Canada
State/province [31] 0 0
Quebec
Country [32] 0 0
Canada
State/province [32] 0 0
Edmonton
Country [33] 0 0
France
State/province [33] 0 0
Bretagne
Country [34] 0 0
France
State/province [34] 0 0
Ile De France
Country [35] 0 0
France
State/province [35] 0 0
Languedoc-Rousillon
Country [36] 0 0
France
State/province [36] 0 0
Limousin
Country [37] 0 0
France
State/province [37] 0 0
Midi-Pyrenees
Country [38] 0 0
France
State/province [38] 0 0
Provence Alpes Cote D'Azur
Country [39] 0 0
France
State/province [39] 0 0
Provence Alpes Cote D'Azu
Country [40] 0 0
France
State/province [40] 0 0
Bordeaux
Country [41] 0 0
France
State/province [41] 0 0
Clermont Ferrand
Country [42] 0 0
France
State/province [42] 0 0
Clichy
Country [43] 0 0
France
State/province [43] 0 0
Creteil Cedex
Country [44] 0 0
France
State/province [44] 0 0
Grenoble Cedex 9
Country [45] 0 0
France
State/province [45] 0 0
Paris, Cedex 14
Country [46] 0 0
France
State/province [46] 0 0
Paris
Country [47] 0 0
France
State/province [47] 0 0
Strasbourg
Country [48] 0 0
France
State/province [48] 0 0
Vandoeuvre les Nancy
Country [49] 0 0
France
State/province [49] 0 0
Villejuif
Country [50] 0 0
Germany
State/province [50] 0 0
Frankfurt am Main
Country [51] 0 0
Germany
State/province [51] 0 0
Hamburg
Country [52] 0 0
Germany
State/province [52] 0 0
Koln
Country [53] 0 0
Germany
State/province [53] 0 0
Mücheln
Country [54] 0 0
Italy
State/province [54] 0 0
Milano
Country [55] 0 0
Italy
State/province [55] 0 0
San Giovanni Rotondo
Country [56] 0 0
Italy
State/province [56] 0 0
Torino
Country [57] 0 0
New Zealand
State/province [57] 0 0
North Island
Country [58] 0 0
New Zealand
State/province [58] 0 0
South Island
Country [59] 0 0
Puerto Rico
State/province [59] 0 0
San Juan
Country [60] 0 0
Spain
State/province [60] 0 0
Madrid
Country [61] 0 0
Spain
State/province [61] 0 0
Barcelona
Country [62] 0 0
Spain
State/province [62] 0 0
Sevilla
Country [63] 0 0
Spain
State/province [63] 0 0
Valencia
Country [64] 0 0
United Kingdom
State/province [64] 0 0
England
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Scotland
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Portsmouth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02292706
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.
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02292706