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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01726400




Registration number
NCT01726400
Ethics application status
Date submitted
9/11/2012
Date registered
14/11/2012
Date last updated
10/11/2015

Titles & IDs
Public title
In Hepatitis C Patients Treated With Interferon and Ribavirin, Does Hepcidin Contribute to Treatment Induced Anaemia
Scientific title
Is Hepcidin a Possible Contributor to Impaired Iron Mobilization and Anaemia in Hepatitis C Patients Treated With Pegylated Interferon Alpha and Ribavirin Therapy? A Pilot Study
Secondary ID [1] 0 0
HEPCIDIN-11/225
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Pegylated interferon alpha
Treatment: Drugs - Ribavirin

Interferon and ribavirin - Treatment with standard of care pegylated interferon alpha and ribavirin.


Treatment: Drugs: Pegylated interferon alpha
Subcutaneous weekly pegylated interferon alpha and daily oral ribavirin treatment as per standard treatment. The dosages for interferon and ribavirin are as per therapeutic guidelines and are based on weight, genotype and previous treatments.

Treatment: Drugs: Ribavirin
Subcutaneous weekly pegylated interferon alpha and daily oral ribavirin treatment as per standard treatment. The dosages for interferon and ribavirin are as per therapeutic guidelines and are based on weight, genotype and previous treatments.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hepcidin levels
Assessment method [1] 0 0
To measure changes in serum hepcidin levels during pegylated interferon alpha and ribavirin therapy in subjects with chronic hepatitis C infection.
Timepoint [1] 0 0
Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24.
Secondary outcome [1] 0 0
iron metabolism markers
Assessment method [1] 0 0
To measure changes in iron metabolism (reticulocyte haemoglobin, serum iron, transferrin saturation and ferritin levels) during pegylated interferon alpha and ribavirin therapy in subjects with chronic hepatitis C infection.
Timepoint [1] 0 0
Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24.
Secondary outcome [2] 0 0
heamolysis markers
Assessment method [2] 0 0
To detect ribavirin induced heamolysis by measuring serum haptoglobin and free haemoglobin during pegylated interferon alpha and ribavirin therapy in subjects with chronic hepatitis C infection.
Timepoint [2] 0 0
Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24.
Secondary outcome [3] 0 0
inosine triphosphatase genetic variants
Assessment method [3] 0 0
To measure the effect of inosine triphosphatase genetic variants on anemia during pegylated interferon alpha and ribavirin therapy in subjects with chronic hepatitis C infection.
Timepoint [3] 0 0
Baseline
Secondary outcome [4] 0 0
erythropoiesis markers
Assessment method [4] 0 0
To measure the level of erythropoiesis (IL1, IL6, erythropoietin and reticulocyte) during pegylated interferon alpha and ribavirin therapy in subjects with chronic hepatitis C infection.
Timepoint [4] 0 0
Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24.

Eligibility
Key inclusion criteria
* Any patient with hepatitis C eligible for treatment with pegylated interferon alpha containing regimes.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* less than 18 years of age

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
6160 - Fremantle

Funding & Sponsors
Primary sponsor type
Other
Name
Fremantle Hospital and Health Service
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marius M Van Rijnsoever, MBBS
Address 0 0
South Metropolitan Health Service, Perth Western Australia
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01726400