Effect of Camel Milk on Chronic Hepatitis C

NCT02216045 | Completed Phase 2 DMC

• 1 other identifier: Mashhad UMS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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 .

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C ,Chronic Hepatitis C ,camel milk

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Complete early virological response (cEVR)

  12 weeks after initiation of treatment

• o Complete early virological response (cEVR)

  12 weeks after initiation of treatment

• o Sustained virological response (SVR)

  12 weeks after initiation of treatment

• o Sustained virological response (SVR)

  12 weeks after initiation of treatment

• o Normalization of ALT( Alanine Aminotransferase)

  during the treatment and 12 weeks of treatment

Study Arms (2)

Peginterferon ,Ribavirin

ACTIVE COMPARATOR

drug :Peginterferon, Ribavirin,

Drug: Peginterferon, Ribavirin

Peginterferon, Ribavirin, camel milk

EXPERIMENTAL

drug :Peginterferon, Ribavirin, camel milk

Drug: Peginterferon, Ribavirin, camel milk

Interventions

Peginterferon, Ribavirin, camel milk DRUG

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.

Also known as: PEGASYS® COPEGUS®. Dromedary milk (camel milk )

Peginterferon, Ribavirin, camel milk

Peginterferon, Ribavirin DRUG

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.

Also known as: PEGASYS® (Peginterferon ) , COPEGUS® (Ribavirin)

Peginterferon ,Ribavirin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HCV (hepatitis C virus ) RNA positive
• Age age groups (18 to 70 years)

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (2)

Faculty of Traditional Medicine

Mashhad, Razavi Khorasan Province, Iran

Location

Mashhad University of Medical Sciences

Mashhad, Razavi Khorasan Province, Iran

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Seyyd Musa Al-Reza Hosseini, professor.As

  Ghaem Gastrointestinal Clinic

  STUDY CHAIR

• Mehdi Yousefi, MD.Phd

  Faculty of Traditional Medicine Clinic

  STUDY DIRECTOR

• Mohammadreza Noras, Phd student

  Faculty of Traditional Medicine Clinic

  PRINCIPAL INVESTIGATOR

• Ali Taghipour, MD.Phd

  MUMS Faculty of Health Sciences

  STUDY DIRECTOR

• Said Zibae, MD.Phd

  Razi vaccine and serum Research Institue of Mashhd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd student

Study Record Dates

• First Submitted: July 26, 2014
• First Posted: August 13, 2014
• Study Start: June 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 29, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

IR (2)