Treatment of Recently Acquired Hepatitis C Virus Infection

Acute Hepatitis C Clinical Trial

— ATAHC-II  

Official title:

Treatment of Recently Acquired Hepatitis C Virus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336010
• Other study ID #: 5R01DA015999-07
• Status: Completed
• Phase: Phase 4
• First received: April 13, 2011
• Last updated: August 31, 2015
• Start date: August 2011
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

To determine whether response guided treatment with pegylated interferon +/- ribavirin is effective for the treatment of recently acquired hepatitis C infection. Response guided treatment is when the length of treatment is determined by how quickly you respond to the treatment.

Description:

A prospective longitudinal study of natural history and treatment outcomes following response guided treatment of recent hepatitis C infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Male and female patients = 16 years of age

• Recent hepatitis C infection with an estimated duration of Infection = 18 months defined as

A)

• i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and

• ii) Documented anti-HCV antibody negative or HCV RNA negative within the 24 months prior to anti-HCV antibody positive result

OR

B)

• i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and

• ii) acute clinical hepatitis (jaundice or ALT> 10 X ULN) within the 12 months prior to first positive HCV antibody or HCV RNA with no other cause of acute hepatitis identifiable and

• Adequate English to provide written, informed consent and to provide reliable responses to the study interview

• Provision of written, informed consent.

Exclusion Criteria:

All patients:

• Individuals considered by the study investigators to be unlikely to participate in intensive follow-up and/or unwilling to provide extra blood samples

Treatment group only:

• Age between 16 and 18 years

• Women with ongoing pregnancy or breast feeding

• Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) *6 months prior to the first dose of study drug

• Any investigational drug <6 weeks prior to the first dose of study drug

• Positive test at screening for anti-HAV IgM Ab, anti-HBc IgM Ab

• History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g. hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)

• History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease

• Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening

• Serum creatinine level >1.5 times the upper limit of normal at screening

• Hgb< 12g/dL in women or < 13g/dL in men at screening (for patients who receive combination therapy with PEG-IFN and ribavirin only)

• Male partners of women who are pregnant (for patients who receive combination therapy with PEG-IFN and ribavirin only)

• History of a severe seizure disorder or current anticonvulsant use

• History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study

• History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease

• Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Virus Diseases

Intervention

Drug:
• Peginterferon alfa-2a
PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly
• Ribavirin
Genotype 1: 1000mg or 1200mg p.o. daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing = 75kg) Genotypes 2/3: 800mg daily p.o. daily in split doses for genotype 2 and 3 patients

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Kirketon Road Centre	Darlinghurst	New South Wales
Australia	St Vincent's Hospital	Darlinghurst	New South Wales
Australia	Alfred Hospital	Melbourne	Victoria
Australia	St Vincent's Hospital Melbourne	Melbourne	New South Wales
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Nepean Hospital	Penrith	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Kirby Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the safety and efficacy of response-guided pegylated interferon and ribavirin for the treatment of recent HCV infection. Response-guided means the duration of treatment will be determined by the subject's early response to treatment.	Treatment duration will be determined by time to undetectable HCV RNA. Undetectable at week 2=8 weeks of therapy; Undetectable at week 4=16 weeks of therapy; Undetectable at week 6=24 weeks of therapy; Undetectable at week 8=32 weeks of therapy (24 weeks for genotypes 2/3); Undetectable at week 12=48 weeks of therapy (24 weeks for genotypes 2/3);	8-48 weeks	Yes