Y- Shaped Pegylated Interferon (YPEG-IFNα-2a) Plus Ribavirin in Egyptian Patients With Untreated Chronic Hepatitis C

NCT01327729 | Unknown Phase 2 DMC

• 1 other identifier: CHT00234
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to assess the efficacy, dosing, safety and tolerance of Y- shaped pegylated interferon (YPEG-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and with no prior treatment for hepatitis C virus (HCV). Methods: Randomized, Open-label trial, in 3 parallel groups (each of 100 patients)

Conditions

Self Efficacy; Hepatitis C

Keywords

pegylated interferon; interferon; HCV; genotype 4

Outcome Measures

Primary Outcomes (1)

• viral clearance at 72 weeks

  assessment of the efficacy, dosing, safety and tolerability of Y- shaped pegylated interferon (YPEG-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and with no prior treatment for HCV.

  72 weeks

Secondary Outcomes (1)

• interferon level

  12 weeks

Study Arms (3)

YPEG-IFN α-2a one week

ACTIVE COMPARATOR

this arm will be treated with: YPEG-IFN α-2a 180mcg/ week for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks

Drug: pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg

YPEG-IFN α-2a Ten days

ACTIVE COMPARATOR

this arm will be treated with: YPEG-IFN α-2a 180mcg/10 days for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks

Drug: pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg

YPEG-IFN α-2a two weeks

ACTIVE COMPARATOR

The third group will be treated with: YPEG-IFN α-2a 180mcg/ 2 weeks for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks.

Drug: pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg

Interventions

pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg DRUG

YPEG-IFN α-2a 180mcg dose form: subcutaneous dosage : 180 mcg frequency every week or ten days or 2 weeks according to the group

Also known as: YPEG-IFN α-2a 180mcg, YPEG, pegylated interferon

YPEG-IFN α-2a Ten days; YPEG-IFN α-2a one week; YPEG-IFN α-2a two weeks

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years and \< 65 years
• Chronic hepatitis C defined as: HCV antibodies using a third generation test; HCV-RNA positive by PCR; liver biopsy in the past 12 months; METAVIR score of A1 and F0 or higher
• Patients never treated with ribavirin, Interferon or PEG-Interferon
• Normal albumin, prothrombin time \> 60%; normal bilirubin
• Alpha-foeto-protein \< 3 times the normal range for the laboratory reference
• HBs antigen negative
• Anti Bilharzial antibodies if positive rectal snip shall be done. The examination may be repeated after praziquantel treatment for those with a positive test
• Hemoglobin \> 11g/dl, leucocytes \> 3000/mm3, neutrophils \> 1500/mm3, platelets \> 100 000/mm3, blood creatinin \< 1.4 mg/dl
• Normal TSH (subjects needing treatment to maintain TSH within a normal range may be included if other eligibility criteria are respected)
• Anti-nuclear antibodies \< 1/160
• Fasting blood sugar between 70-115mg/dl ; if glucose intolerance or diabetes, HbA1C \< 8.5%
• Normal ophthalmologic examination in patients with history of blood pressure and/or diabetes
• Effective contraception (IUD, diaphragm and spermicide, condoms and spermicides, oral contraceptive, progesterone implants (Norplant), medroxyprogesterone acetate (Depo-provera), tubal ligation, vasectomy) during the treatment period for females. No breastfeeding during the study period
• Signed informed consent

You may not qualify if:

• Other liver diseases associated with chronic hepatitis C: co-infection with hepatitis B (positive HBs antigen); hemochromatosis; alpha-1 anti-trypsin deficiency; Wilson disease; alcoholism-related liver disease; Gilbert disease
• Alcohol intake \> 50g/day for males and 40 g/day for females
• Ongoing intravenous drug use
• Aggravated liver cirrhosis: history or presence of ascitis, oesophageal varicosis, liver encephalopathy
• Hepatocellular carcinoma

Sponsors & Collaborators

• BioGeneric Pharma: lead
• Xiamen Amoytop Biotech Co., Ltd.: collaborator

Study Sites (1)

Kasr Alaini school of medicne

Cairo, Cairo Governorate, 11559, Egypt

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Gamal Esmat, MD

  cairo university - Kasr alaini school of medicine

  PRINCIPAL INVESTIGATOR

• Mohamed Karim F Ashour, MD

  Cairo university- Kasr Alaini school of medicine

  STUDY DIRECTOR

Central Study Contacts

Mohamed Karim f Ashour, MD

CONTACT

0020123130102; drmkarim@gmail.com

Gamal Esmat, MD

CONTACT

002012455468; g_esmat@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2011
• First Posted: April 4, 2011
• Study Start: November 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2013
• Last Updated: April 4, 2011

Record last verified: 2011-03

Locations

EG (1)