Chronic Hepatitis C
Conditions
Keywords
Hepatitis C ,Chronic Hepatitis C ,camel milk
Brief summary
Camel milk as the new modality for treatment of chronic hepatitis C. The purpose of this study is to evaluate effectiveness and safety of camel milk in combination with Peginterferon Alfa-2a and Ribavirin in genotype 2,3 chronic hepatitis C virus .
Detailed description
The investigators enrolled 40 patients into the study. Group 1(Intervention ) : received PEGASYS( Peginterferon ) One subcutaneous injection containing 0.5 ml solution with180 mcg per week plus COPEGUS( Ribavirin ) tablets (body-weight adjusted dose: \< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily and 250 ml of raw camel milk will be consumed in 10 minutes orally twice daily for 12 weeks. Group 2 ( control ): received PEGASYS( Peginterferon ) One subcutaneous injection containing 0.5 ml solution with180 mcg per week plus COPEGUS( Ribavirin ) tablets (body-weight adjusted dose: \< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for 12 weeks. Follow up period is 1,2,3 months after treatment. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid) on the first months after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the third month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.
Interventions
DRUGPeginterferon, Ribavirin, camel milk
Peginterferon One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks. Ribavirin (RBV) tablets (body-weight adjusted dose: \< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks . camel milk 250 ml of raw camel milk will be consumed in 10 minutes orally twice daily for 12 weeks.
DRUGPeginterferon, Ribavirin
Peginterferon (PegIFNα-2a) One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks. Ribavirin (RBV) tablets (body-weight adjusted dose: \< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks.
Sponsors
Mashhad University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* HCV (hepatitis C virus ) RNA positive * Age age groups (18 to 70 years)
Exclusion criteria
* Ongoing pregnancy or breast feeding * Hx of HCC(hepatocellular carcinoma ) * Hx of alcoholic liver disease * Hx of bleeding from esophageal varices * Hx of hemochromatosis * Hx of autoimmune hepatitis * Hx of Suicidal attempt * Hx of cerebrovascular dis * Hx of severe retinopathy * Hx of severe psoriasis * Hx of scleroderma * Hx of metabolic liver disease * Hx of SLE(systemic lupus erythematosus )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early Virologic Responses(EVR) | After 4 weeks of Treatment | Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment by PEG IFN ( interferon) + RBV. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| o Complete early virological response (cEVR) | 12 weeks after initiation of treatment | defined by undetectable HCV RNA at 12 weeks post initiation of dual therapy by PEG IFN + RBV+camel milk |
| o Sustained virological response (SVR) | 12 weeks after initiation of treatment | defined by HCV RNA below the detection limit based on quantitative PCR 12 weeks after stopping treatment by PEG IFN +RBV |
| Complete early virological response (cEVR) | 12 weeks after initiation of treatment | defined by undetectable HCV RNA at 12 weeks post initiation of dual therapy by PEG IFN + RBV |
| o Normalization of ALT | during the treatment and 12 weeks of treatment | Proportion of patients who have ALT below the upper limit of normal (ULN) during the treatment by PEG IFN +RBV+camel milk and 12 weeks after of treatment. |
| o Adverse events(AE) | Up to 12 weeks | Number of participants experiencing adverse events |
| o Normalization of ALT( Alanine Aminotransferase) | during the treatment and 12 weeks of treatment | Proportion of patients who have ALT below the upper limit of normal (ULN) during the treatment by PEG IFN +RBV and 12 weeks after the end of treatment. |
Countries
Iran
Outcome results
None listed