Hepatitis CNCT02485262
Outcome of New Direct Acting Agents For Hepatitis C A Community Based Experience
An observational study of Hepatitis C, run by Arrowhead Regional Medical Center at 1 site in United States.
Trial summary
Chronic Hepatitis C virus (HCV) infection is the leading cause of advanced liver disease worldwide. The virus successfully evades host immune detection and has highly restricted requirements for growth in vitro that for many years hampered efforts to find a safe, uncomplicated, and reliable oral antiviral therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Sofosbuvir and simeprevir
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Nov 2016
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Targeted subjects are HCV patients are ARMC who received one of the SOF based treatment regimens from December 20, 2013 to May 2015
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Zeid Kayali, MD,MBA contact
Tina Mercado contact
United States1 site, 1 recruiting
- Recruiting
Arrowhead Regional Medical Center
Colton, California, 92347
Tina Mercado, 909-883-2999
Zeid Kayali, MD, 909 883-2999
About this study
Official title: Outcome of New Direct Acting Agents For Hepatitis C
Chronic Hepatitis C virus (HCV) infection is the leading cause of advanced liver disease worldwide. The virus successfully evades host immune detection and has highly restricted requirements for growth in vitro that for many years hampered efforts to find a safe, uncomplicated, and reliable oral antiviral therapy. Ten years after discovery, pegylated interferon-alpha and ribavirin (PR) treatment for 24-48 weeks became the standard of care (1-5). PR therapy offered limited performance and availability across the diverse spectrum of HCV disease and was fraught with excessive and often limiting side effects. The first direct acting agents (DAAs) were protease inhibitors (PIs) that were introduced in 2011 and could only be used only in combination with PR because of concerns for rapid PI viral resistance. Although the first generation PIs added increased efficacy to the PR regimen, they also added new side effects and untoward drug interactions (6-8). Sofosbuvir (SOF) is a potent nucleoside inhibitor (NI) that has recently been approved for treatment of HCV. The drug has low toxicity, high resistance barrier, and minimal drug interactions with other HCV DAAs such as PIs and anti-NS5A agents. SOF is safe and effective across different viral genotypes, disease stages, and special patient groups such as those co-infected with HIV. When used in combination with ribavirin or another DAA, SOF has revolutionized the HCV treatment spectrum and set the stage for nearly universal HCV antiviral therapy. Sustained virologic response (SVR12) for SOF plus ribavirin and pegylated interferon (PR) is 90% for genotype 1 and 85-94% for genotypes 2 and 3 (9-16). SOF plus simeprevir (protease inhibitor) showed a 94% SVR12 for genotype 1 (9-16). More so than any other anti-HCV drug developed to date, SOF offers the widest applicability for all infected patients yet can be given in a personalized regimen to maximize performance
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- Sofosbuvir and simeprevir
- Keywords
- Protease inhibitor treatment
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir and simeprevirDrug
Also called Sovaldi and Olysio
Hepatitis C treatment using Direct Acting Agents
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR 12
Measured: 12 weeks post treatment
Secondary outcomes (1)
Safety and Tolerability as measured by the number of participants with AEs, Change in baseline laboratory results
Number of participants with AEs, Change in baseline laboratory results
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startNov 2013
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Arrowhead Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeid Kayali, MD, Arrowhead Regional Medical Center
- Investigators
- Zeid Kayali, MD,MBA, Principal investigator, Arrowhead Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485262
- Sponsor's protocol ID
- 1234
- Other IDs
- 14-25
- Status last verified
- Jun 2015
- First submitted
- 19 Jun 2015
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24209977Gane 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.
PubMed 20951424Lawitz 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.
PubMed 23607594
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of New Direct Acting Agents For Hepatitis C
- ClinicalTrials.gov ID
- NCT02485262
- Acronym / sponsor ID
- 1234
- Conditions
- Hepatitis C
- Keywords
- Protease inhibitor treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Arrowhead Regional Medical CenterUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic Hepatitis C virus (HCV) infection is the leading cause of advanced liver disease worldwide. The virus successfully evades host immune detection and has highly restricted requirements for growth in vitro that for many years hampered efforts to find a safe, uncomplicated, and reliable oral antiviral therapy. Ten years after discovery, pegylated interferon-alpha and ribavirin (PR) treatment for 24-48 weeks became the standard of care (1-5). PR therapy offered limited performance and availability across the diverse spectrum of HCV disease and was fraught with excessive and often limiting side effects. The first direct acting agents (DAAs) were protease inhibitors (PIs) that were introduced in 2011 and could only be used only in combination with PR because of concerns for rapid PI viral resistance. Although the first generation PIs added increased efficacy to the PR regimen, they also added new side effects and untoward drug interactions (6-8). Sofosbuvir (SOF) is a potent nucleoside inhibitor (NI) that has recently been approved for treatment of HCV. The drug has low toxicity, high resistance barrier, and minimal drug interactions with other HCV DAAs such as PIs and anti-NS5A agents. SOF is safe and effective across different viral genotypes, disease stages, and special patient groups such as those co-infected with HIV. When used in combination with ribavirin or another DAA, SOF has revolutionized the HCV treatment spectrum and set the stage for nearly universal HCV antiviral therapy. Sustained virologic response (SVR12) for SOF plus ribavirin and pegylated interferon (PR) is 90% for genotype 1 and 85-94% for genotypes 2 and 3 (9-16). SOF plus simeprevir (protease inhibitor) showed a 94% SVR12 for genotype 1 (9-16). More so than any other anti-HCV drug developed to date, SOF offers the widest applicability for all infected patients yet can be given in a personalized regimen to maximize performance
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Targeted subjects are HCV patients are ARMC who received one of the SOF based treatment regimens from December 20, 2013 to May 2015
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sofosbuvir and simeprevirAlso: Sovaldi and OlysioHepatitis C treatment using Direct Acting Agents | Drug | – |
Primary outcome
SVR 12
Time frame: 12 weeks post treatment
1 secondary outcome
Safety and Tolerability as measured by the number of participants with AEs, Change in baseline laboratory results
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
- Results publication: PubMed 24209977Lawitz 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.
- Results publication: PubMed 20951424Gane 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.
- Results publication: PubMed 23607594Lawitz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeid Kayali, MD,MBA contact
Tina Mercado contact
Zeid Kayali, MD,MBA principal investigator
Arrowhead Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Arrowhead Regional Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeid Kayali, MD,MBA (909 883-2999), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVR 12 (time frame: 12 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02485262, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2015.