- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02485262
Outcome of New Direct Acting Agents For Hepatitis C A Community Based Experience
Outcome of New Direct Acting Agents For Hepatitis C
Study Overview
Detailed Description
SOF plus simeprevir or PR became the backbone of HCV treatment. The demographics and characteristics of HCV patients in the Inland Empire are different than the cohort enrolled in SOF trials. There is a need to determine if the community based outcomes at match the outcome reported in the clinical trials.
Aim of the study
To propectively evaluate the efficacy and tolerability of the SOF treatment regimens prescribed at the ARMC and compare them to outcomes reported in the clinical trials that were the basis for FDA approval.
Study Description
This is a prospective registry study conducted at the ARMC. Targeted subjects are HCV patients are ARMC who received one of the SOF based treatment regimens from December 20, 2013 to December 19, 2014.
Primary end Point is sustained virological response at 12 weeks (SVR 12) and secondary end point is compliance and safety. Safety and compliance will be determined based on symptoms reported during clinic visits and number of refills and doses dispensed for every patient.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Zeid Kayali, MD,MBA
- Phone Number: 909 883-2999
Study Contact Backup
- Name: Tina Mercado
- Phone Number: 909 883-2997
Study Locations
-
-
California
-
Colton, California, United States, 92347
- Recruiting
- Arrowhead Regional Medical Center
-
Contact:
- Tina Mercado
- Phone Number: 909-883-2999
-
Contact:
- Zeid Kayali, MD
- Phone Number: 909 883-2999
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult Chronic HCV patients aged >18
- Treatment naïve
- Patient with cirrhosis and no cirrhosis. Cirrhosis defined as stage 4 fibrosis on liver biopsy or Fibro sure results indicating cirrhosis or has clinical findings suggestive of cirrhosis
- Patients meet the indication to receive one of the SOF treatment based regimens
Exclusion Criteria:
- Co-infected patients with HIV or Hepatitis B
- Patient received one of the DAAs regimens
- Patient with active substance abuse and alcohol abuse
- Patient received prior DAA regimen
- Decompensated cirrhotic patients
- Patient has contraindication to receive SOF
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SVR 12
Time Frame: 12 weeks post treatment
|
12 weeks post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerability as measured by the number of participants with AEs, Change in baseline laboratory results
Time Frame: 24 weeks
|
Number of participants with AEs, Change in baseline laboratory results
|
24 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Zeid Kayali, MD,MBA, Arrowhead Regional Medical Center
Publications and helpful links
General Publications
- Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, Schultz M, Davis MN, Kayali Z, Reddy KR, Jacobson IM, Kowdley KV, Nyberg L, Subramanian GM, Hyland RH, Arterburn S, Jiang D, McNally J, Brainard D, Symonds WT, McHutchison JG, Sheikh AM, Younossi Z, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 May 16;368(20):1878-87. doi: 10.1056/NEJMoa1214853. Epub 2013 Apr 23.
- Lawitz E, Poordad FF, Pang PS, Hyland RH, Ding X, Mo H, Symonds WT, McHutchison JG, Membreno FE. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Lancet. 2014 Feb 8;383(9916):515-23. doi: 10.1016/S0140-6736(13)62121-2. Epub 2013 Nov 5. Erratum In: Lancet. 2014 Mar 8;383(9920):870.
- Gane EJ, Roberts SK, Stedman CA, Angus PW, Ritchie B, Elston R, Ipe D, Morcos PN, Baher L, Najera I, Chu T, Lopatin U, Berrey MM, Bradford W, Laughlin M, Shulman NS, Smith PF. Oral combination therapy with a nucleoside polymerase inhibitor (RG7128) and danoprevir for chronic hepatitis C genotype 1 infection (INFORM-1): a randomised, double-blind, placebo-controlled, dose-escalation trial. Lancet. 2010 Oct 30;376(9751):1467-75. doi: 10.1016/S0140-6736(10)61384-0. Epub 2010 Oct 14.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Sofosbuvir
- Simeprevir
Other Study ID Numbers
- 1234 (Department of Defense)
- 14-25 (Other Identifier: 14-25)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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