Effect of Camel Milk on Chronic Hepatitis C

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigating the Effects of Camel Milk Products on the Laboratory Markers in the Patients With Chronic Hepatitis C, Genotype 2 & 3

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Peginterferon, Ribavirin, camel milk
* Drug: Peginterferon, Ribavirin


Participation Criteria
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Eligibility Criteria
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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 )

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peginterferon ,Ribavirin<br>drug :Peginterferon, Ribavirin, | Drug: Peginterferon, Ribavirin<br>* 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.<br>* Other names: PEGASYS® (Peginterferon ) , COPEGUS® (Ribavirin);|
| Experimental: Peginterferon, Ribavirin, camel milk<br>drug :Peginterferon, Ribavirin, camel milk | Drug: Peginterferon, Ribavirin, camel milk<br>* 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.<br>* Other names: PEGASYS® COPEGUS®. Dromedary milk (camel milk );|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Virologic Responses(EVR) | 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. | After 4 weeks of Treatment | 
| Early Virologic Responses(EVR) | Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment by PEG IFN + RBV+camel milk | 4 weeks after of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete early virological response (cEVR) | defined by undetectable HCV RNA at 12 weeks post initiation of dual therapy by PEG IFN + RBV | 12 weeks after initiation of treatment | 
| o Complete early virological response (cEVR) | defined by undetectable HCV RNA at 12 weeks post initiation of dual therapy by PEG IFN + RBV+camel milk | 12 weeks after initiation of treatment | 
| o Sustained virological response (SVR) | defined by HCV RNA below the detection limit based on quantitative PCR 12 weeks after stopping treatment by PEG IFN +RBV | 12 weeks after initiation of treatment | 
| o Sustained virological response (SVR) | defined by HCV RNA below the detection limit based on quantitative PCR(polymerase chain reaction ) 12 weeks after stopping treatment by PEG IFN +RBV+camel milk | 12 weeks after initiation of treatment | 
| o Normalization of ALT( Alanine Aminotransferase) | 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. | during the treatment and 12 weeks of treatment | 
| o Normalization of ALT | 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. | during the treatment and 12 weeks of treatment | 
| o Adverse events(AE) | Number of participants experiencing adverse events | Up to 12 weeks | 
| o Adverse events(AE) | Number of participants discontinuing study treatment because of adverse events | Up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C ,Chronic Hepatitis C ,camel milk