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DAA-based Therapy for Recently Acquired Hepatitis C II (DAA = Directly Acting Antiviral) (DARE-C II)

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ClinicalTrials.gov Identifier: NCT02156570
Recruitment Status : Completed
First Posted : June 5, 2014
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Kirby Institute

Brief Summary:

The purpose of the study is to examine whether patients who have acute or early chronic hepatitis C virus (HCV) infection can be treated effectively and safely with an interferon-sparing regimen that combines a new direct acting antiviral drug (sofosbuvir) with one of the standard treatments for chronic hepatitis C (ribavirin). In particular, this study will investigate whether treatment of acute or early chronic HCV can be shortened. The study will assess efficacy by looking at the proportion of people who clear the virus (have no virus detectable in their blood) at the end of treatment, and 1, 3 and 6 months after treatment.

The hypothesis is that short course (6 weeks) dual therapy using sofosbuvir and RBV will result in successful virological eradication in the majority (≥80%) of subjects treated for recently acquired HCV.


Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Sofosbuvir and ribavirin Phase 4

Detailed Description:

To evaluate the efficacy, safety and acceptability of an interferon-sparing strategy with sofosbuvir and ribavirin for the treatment of recently acquired HCV infection.

An open label single arm multicentre study Treatment of participants: Sofosbuvir 400mg daily with weight based ribavirin (1000mg <75 kg, 1200mg >/= 75kg) Duration of treatment will be 6 weeks for all subjects followed by 52 weeks of observational follow-up Total study duration = 58 weeks Primary endpoint: SVR 12


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Interferon Sparing Strategy of Sofosbuvir Plus Ribavirin for the Treatment of Recently Acquired Hepatitis C Infection
Study Start Date : October 2014
Actual Primary Completion Date : August 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sofosbuvir and ribavirin

Sofosbuvir tablet 400 mg daily Ribavirin tablet weight based dosing (1000mg <75 kg, 1200mg >/= 75kg) daily

Treatment will be for 6 weeks in all participants.

Drug: Sofosbuvir and ribavirin
Sofosbuvir 400mg daily plus weight-based dosing ribavirin (1000mg <75kg, 1200mg >/= 75 kg) Treatment will be for 6 weeks in all participants.
Other Names:
  • Sovaldi
  • Copegus




Primary Outcome Measures :
  1. SVR 12 [ Time Frame: 12 weeks post treatment ]
    Proportion of patients with undetectable HCV RNA by TaqMan 12 weeks after therapy completion (SVR 12 - Week 18)


Secondary Outcome Measures :
  1. SVR 24 [ Time Frame: 24 weeks post treatment ]
    Proportion of patients with undetectable HCV RNA by TaqMan 24 weeks after therapy completion (SVR 24 - Week 30)


Other Outcome Measures:
  1. End of treatment response [ Time Frame: End of treatment week 6 ]
    Proportion of patients with undetectable HCV RNA at end of therapy (ETR - week 6)

  2. SVR 4 [ Time Frame: 4 weeks post treatment ]
    Proportion of patients with undetectable HCV RNA by TaqMan 4 weeks after therapy completion (SVR 4 - Week 10)

  3. Follow up 1 year [ Time Frame: 1 year post treatment ]
    Proportion of patients with undetectable HCV RNA at end of study follow-up (FU1 - Week 58)

  4. Undetectable HCV RNA [ Time Frame: Week 1, 2, 3 and 4 of treatment ]
    Proportion of patients with undetectable HCV RNA at weeks 1, 2, 3 and 4

  5. Indicators of toxicity (ALT, HB, Neutrophils, Platelets) [ Time Frame: Baseline until week 4 of treatment ]
    To evaluate indicators of toxicity (ALT, HB, Neutrophils, Platelets) during therapy

  6. Plasma ribavirin levels and haemoglobin [ Time Frame: Baseline to week 4 of treatment ]
    To correlate plasma ribavirin levels with treatment outcome and changes in haemoglobin during therapy

  7. Incidence of reinfection [ Time Frame: End of treatment until follow up 1 year ]
    Incidence of reinfection after documented SVR



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of written informed consent
  • Male and female patients aged 18 years and above
  • Willing to use two effective methods of contraception during the treatment period and 24 weeks post.
  • HBsAg negative
  • Detectable HCV RNA at screening (>10,000 IU/ml), and in the opinion of the investigator is unlikely to demonstrate spontaneous viral clearance
  • Compensated liver disease (Child-Pugh A)
  • Negative pregnancy test at screening and 24 hours prior to first dose of study drugs
  • Medically stable on the basis of physical examination, medical history and vital signs
  • Adequate English to provide reliable responses to the study questionnaires
  • Recent hepatitis C infection, as defined by: A) i) First anti-HCV Ab or HCV RNA positive within the previous 6 months and ii) Documented anti-HCV Ab negative within the 24 months prior to anti-HCV antibody positive result, OR B) i) First anti-HCV Ab or HCV RNA positive within the previous 6 months and ii) acute clinical hepatitis (jaundice or ALT> 10 X ULN) within the previous 12 months prior to first positive HCV antibody or HCV RNA, with no other cause of acute hepatitis identifiable

If co-infection with HIV is documented, the subject must meet the following criteria:

  • Antiretroviral (ARV) untreated for >8 weeks preceding screening visit with CD4 T cell count >500 cells/mm3 OR
  • On a stable ARV regimen for >8 weeks prior to screening visit, with CD4 T cell count >200 cells/mm3 and an undetectable plasma HIV RNA level.

Exclusion Criteria:

  • Standard exclusions to RBV therapy
  • Pregnancy/lactation or male subjects whose female partners are pregnant
  • Subject has a history of decompensated liver disease: history of ascites, hepatic encephalopathy, or bleeding oesophageal varices, and/or any of the following screening laboratory results: a.INR of ≥1.5; Serum albumin <3.3 g/dL; Serum total bilirubin >1.8 times upper limit of normal, unless isolated in subjects with Gilbert's syndrome.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156570


Locations
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Australia, New South Wales
St Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
New Zealand
Auckland City Hospital
Auckland, Grafton, New Zealand, 1023
Sponsors and Collaborators
Kirby Institute
Investigators
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Principal Investigator: Gail Matthews, MbChB FRACP Kirby Institute

Additional Information:
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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT02156570     History of Changes
Other Study ID Numbers: VHCRP1206
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018

Keywords provided by Kirby Institute:
Hepatitis C
Acute/early chronic
Recently acquired
Directly acting antiviral therapy
Sofosbuvir
Ribavirin

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Sofosbuvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents