Wednesday, October 5, 2016

October Recruiting and upcoming hepatitis C clinical trials 

Recruiting and upcoming hepatitis C clinical trials 

The clinical trials listed on this page can be found online at at A Web site maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). This is not a complete list of clinical trials, to find out if a study is enrolling patients in your area please click here

For viral hepatitis clinical trials listed by state visit CenterWatch. CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties.

To learn more about drugs used to treat hepatitis C I highly suggest you begin with this incredible new blog recently launched by HCV Advocate; HCV Medications Blog. The blog is easy to navigate with treatment information listed clearly by HCV genotype.

As a reference point the following news and research articles correlate with the drugs used in this small list of clinical trials.

News and Research

GS-9857 (voxilaprevir), in combination with sofosbuvir and velpatasvir
Oct 20
Gilead SVR12 Rates SOF/VEL/VOX; (GS-9857), Treatment-Naïve/Treatment-Experienced HCV Geno 1-6
Gilead Announces SVR12 Rates From Four Phase 3 Studies of a Once-Daily, Fixed-Dose Combination of Sofosbuvir, Velpatasvir and Voxilaprevir in Treatment-Naïve and Treatment-Experienced Genotype 1-6 Chronic HCV-Infected Patients
- If Approved, SOF/VEL/VOX Would Be the First Once-Daily Single Tablet Regimen Available for Salvage for Patients Who Have Failed Prior HCV Therapy with Oral Direct-Acting Antiviral Agent Regimens -
- U.S. NDA Planned for Q4 2016 -

Oct 2016
NS5B polymerase inhibitor sofosbuvir, NS5A inhibitor velpatasvir, and the new protease inhibitor GS-9857 (voxilaprevir)

April 2016
A triple combination of Gilead Sciences' sofosbuvir, velpatasvir and GS-9857 demonstrated a high sustained response rate for treatment-experienced people with all hepatitis C virus (HCV) genotypes who previously were not cured with prior direct-acting antivirals (DAAs), according to two presentations yesterday at the 2016 International Liver Congress in Barcelona.

Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir (Viekira Pak)
**Currently, VIEKIRA PAK is taken twice daily as three tablets in the morning and one tablet in the evening. VIEKIRA XR is a fixed-dose formulation and is given once-daily as three oral tablets
*Both must be taken with a meal because administration under fasting conditions may result in reduced virologic response and possible development of resistance.

Sept 2016
98 percent of previously untreated genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected patients without cirrhosis achieved SVR12 in Phase 3b GARNET study.

Glecaprevir (ABT-493)/Pibrentasvir (ABT-530)
Investigational HCV drug combo yields high SVR12 rates in compensated cirrhosis
The ABT-493/ABT-530 investigational direct-acting antiviral combination cured nearly all patients with compensated cirrhosis and genotype 1 or 3 hepatitis C virus infection.

AbbVie's HCV Regimen glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) Receives FDA Breakthrough Therapy Designation
Sept. 30, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor.​

MK-3682 with MK-8408
EASL Conference April 2016
High Efficacy of an 8-Week, 3-Drug Regimen of MK-3682/Grazoprevir/MK-8408 in HCV Genotype 1, 2, or 3-Infected Patients: SVR24 Data from the Phase 2 C-CREST 1 and 2 Studies

August 2016
Grazoprevir plus ribavirin linked to rapid, sustained suppression of HCV RNA
“Overall, the tolerability and safety profile of [grazoprevir] plus [ribavirin] were largely consistent with the well-reported safety profile of [ribavirin],” Gane and colleagues wrote. “The combination of [grazoprevir] plus [ribavirin] was associated with rapid virologic suppression, with 84% of patients in the [per-protocol] population achieving undetectable HCV RNA by [treatment week 4] and 88% (22/25) achieving undetectable HCV RNA at the end of 12 weeks of therapy.”

Elbasvir/grazoprevir (Zepatier®)
May 2016
Elbasvir/Grazoprevir: A Review of the Latest Agent in the Fight against Hepatitis C
Elbasvir/grazoprevir (Zepatier®) is a combination product with an FDA-approved indication for the treatment of chronic HCV genotypes (GTs) 1 and 4 in adults

Sept 27 2016
Full Text
Effectiveness of Elbasvir and Grazoprevir Combination, With or Without Ribavirin, for Treatment-Experienced Patients with Chronic Hepatitis C Infection
The combination tablet of elbasvir and grazoprevir, with or without ribavirin, was highly efficacious in inducing an SVR12 in patients with HCV genotype 1, 4, or 6 infection failed by previous treatment with peg-interferon and ribavirin, including patients with cirrhosis and/or a prior null response

Article summary @ MPR
Effectiveness of Elbasvir and Grazoprevir Combination, With or Without Ribavirin, for Treatment-Experienced Patients with Chronic Hepatitis C Infection
Fixed-Dose HCV Combo Drug Effective in Hard-to-Treat Patients

United States, Maryland Identifier: NCT02745535
This study will evaluate the safety, tolerability, and efficacy of sofosbuvir/velpatasvir/GS-9857 (SOF/VEL/GS-9857) in adults with chronic hepatitis C infection who have failed to eradicate hepatitis C despite previous combination directly acting antiviral therapy.

United States, Maryland Identifier: NCT02468648
Condition: Chronic Hepatitis C
Interventions: Drug: Sofosbuvir; Drug: GS-5816
Detailed Description:
Up to 140 patients with chronic hepatitis C, genotypes 1-4, who were never treated or previously treated but failed a course of therapy with any interferon and ribavirin combination regimen will be eligible to be enrolled into this pilot study to evaluate the combination of sofosbuvir and GS-5816 as a fixed dose tablet to improve response to antiviral therapy. To enrich the study population with subjects with a greater likelihood of virological relapse after stopping therapy, we plan to enroll a minimum of 60% treatment-experienced subjects and 50% with cirrhosis. These two drugs inhibit key enzymes that are necessary for viral replication. Sofosbuvir, an NS5B polymerase inhibitor is already approved for use in combination with interferon and ribavirin for the treatment of HCV genotype 1 infection. GS-5816 is an NS5A replication complex inhibitor with potent activity against most strains of hepatitis C virus. Combining these two agents into a single pill should improve patient compliance and improve tolerability because interferon and ribavirin will not be part of the regimen. After medical evaluation and liver biopsy, patients will receive combination therapy with sofosbuvir and GS-5816 one pill a day for 12 weeks. The baseline liver biopsy is necessary to assess the amount of liver damage caused by the HCV and to measure expression of genes associated with clearance of HCV. Blood samples will be collected to monitor safety and response to therapy and for research purposes. HCV RNA levels will be monitored frequently for the initial 4 weeks and then at monthly intervals for the remaining 8 weeks of antiviral therapy. All subjects will undergo a second liver biopsy, 4 weeks after starting therapy. The second biopsy is being performed for research purposes so investigators can determine specifically which liver genes are associated with failure of therapy (and response to therapy). Subjects who refuse the second liver biopsy will continue to receive SOF/GS-5816 treatment for the planned 12 week duration Patients in whom serum HCV RNA is greater than or equal to lower limit of quantification (LLOQ) after 2 consecutive HCV RNA < LLOQ or who have a confirmed > 1 log10 increase from nadir will discontinue therapy (because continuing therapy is considered futile i.e. it is unlikely to work). The major endpoints will be changes in interferon stimulated gene and protein expression in the liver and changes in HCV RNA levels in liver and serum between baseline and 4 weeks and rates of sustained virologic response at post-treatment week 12. Secondary endpoints will be safety and sustained virologic response at post-treatment week 24 weeks.

Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Canada (AMBER) Identifier: NCT02581189
This study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) data for the interferon-free ABBVIE REGIMEN ± RBV in participants with chronic hepatitis C (CHC) in a real life setting across clinical practice patient populations in Canada.

Germany Identifier: NCT02615145
The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without Dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions.
This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Germany in a clinical practice patient population.

Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary - VERITAS Identifier: NCT02636608
The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) and work productivity data of the interferon-free regimen of Paritaprevir (PTV)/ritonavir (r) + Ombitasvir (OBV), ± Dasabuvir (DSV), ± Ribavirin in chronic hepatitis C virus infected participants.

United States Australia Belarus France Germany Poland Puerto Rico Russian Federation United Kingdom Identifier: NCT02738138
The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1 co-infection.

United States Identifier: NCT02194998
HIV and hepatitis C virus (HCV) infection are diseases that share the same risk factors and routes of transmission. For this reason, many people infected with HIV are also infected with HCV. Interferon (IFN) is a drug used to treat HCV; however, in people coinfected with HIV and HCV, IFN treatment often does not work well and can cause unwanted side effects. The purpose of this study is to evaluate the safety, tolerability, and effectiveness of IFN-free HCV treatment in HIV/HCV coinfected adults who are taking antiretroviral (ARV) therapy.

United States France Germany Spain Sweden Identifier: NCT02613403
This is a randomized, multicenter, open-label trial of the combination regimen of MK-5172 (grazoprevir [GZR]) (100 mg), MK-3682 (450 mg) and MK-8408 (ruzasvir) (60 mg) for 16 weeks with ribavirin (RBV) or 24 weeks without RBV in cirrhotic (C) or non-cirrhotic (NC) hepatitis C virus (HCV) genotype (GT) 1 or GT3-infected participants who have previously failed a direct-acting antiviral regimen (DAA). The combination regimen will be administered as two fixed-dose combination (FDC) tablets, referred to as MK-3682B, given once-daily.
The study will evaluate the efficacy of the combination regimen of MK-5172 (GZR), MK-3682 and MK-8408 (ruzasvir) with or without ribavirin as assessed by the proportion of participants achieving Sustained Virologic Response 12 weeks (SVR12) after the end of all study therapy.

United States, Texas
Efficacy and Safety of MK-3682 With MK-8408 in Adults With Chronic Hepatitis C Genotype 1, 2, 3, 4, 5 or 6 Infection (MK-3682-035) Identifier: NCT02759315
The study is a single-center, multiple-arm investigation of co-administration of MK-3682 450 mg and MK-8408 60 mg in participants with chronic Hepatitis C Virus (HCV) Genotype (GT)1, GT2, GT3, GT4, GT5, or GT6. The impact of the study treatment regimen on Sustained Virologic Response (SVR)12 (undetectable HCV ribonucleic acid [RNA] 12 weeks after ending study treatment) for each HCV Genotype will be evaluated in cirrhotic participants and non-cirrhotic participants.

Brazil Identifier: NCT02624063
The purpose of the study is to study the combination of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 1.

This study is not yet open for participant recruitment Identifier: NCT02890719
Conditions: Liver Transplantation; Hepatitis C
Pilot, single center, open-label study to evaluate the efficacy and tolerability of Grazoprevir and Elbasvir in HCV GT1 and 4 liver transplant recipients.30 liver transplant recipients with hepatitis C recurrence.
Contact: Xavier Forns, MD +34 93 2275400
Contact: Anna Cruceta, MD +34 93 2275400 ext 4380

Evaluate the Safety and Effectiveness of Sovaldi Treatment Regimens in Patients With Chronic Hepatitis C Virus (HCV) Infection in a Korean Real-World Setting Identifier: NCT02907996
Condition: Hepatitis C Virus
Intervention: Drug: Sofosbuvir

Of Interest
Oct 5
RedHill Announces Initiation of Phase II Study with YELIVA™ in Hepatocellular Carcinoma at the Medical University of South Carolina​

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