Clinical trial NCT01336010: Treatment of Recently Acquired Hepatitis C Virus Infection
Official title: Treatment of Recently Acquired Hepatitis C Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Hepatitis C
Keywords: Hepatitis C
Acute Hepatitis C
Early chronic Hepatitis C
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
First posted: 2011-04-15
Enrollment: 82
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: 8-48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: Kirketon Road Centre
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: St Vincent's Hospital Melbourne
state: New South Wales
city: Penrith
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: University of New South Wales
name: Gregory J Dore, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martinello M, Hellard M, Shaw D, Petoumenos K, Applegate T, Grebely J, Yeung B, Maire L, Iser D, Lloyd A, Thompson A, Sasadeusz J, Haber P, Dore GJ, Matthews GV. Short duration response-guided treatment is effective for most individuals with recent hepatitis C infection: the ATAHC II and DARE-C I studies. Antivir Ther. 2016;21(5):425-34. doi: 10.3851/IMP3035. Epub 2016 Feb 11.