Comparison of the degree and speed of virologic response to two treatment options in patients with chronic Hepatitis C.

Phase 3

Recruiting

• Conditions: chronic hepatitis C; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Infection - Other infectious diseases

• Registration Number: ACTRN12615001111561
• Lead Sponsor: Mostafa Yakoot

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Chronic Hepatitis C genotype 4 infection with HCV RNA levels > 4 Log 10

Exclusion Criteria

Other causes of chronic hepatitis such as hepatitis B or autoimmune hepatitis.
critically ill patients and severe organ dysfunctions

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sustained virologic response (serum HCV RNA below level of quantification at 12 weeks post treatment).[12 weeks after end of treatment];very Rapid Virologic Response (vRVR) (i.e. Serum HCV RNA below level of quantification at the end of week 2 of therapy)[2 weeks after starting treatment];ultra Rapid Virologic Response (i.e. serum HCV RNA below level of quantification or decreased by at least 4 Logs10 at the end of one week of therapy)[1 week after treatment start]

Secondary Outcome Measures

Name	Time	Method
Adverse drug reactions assessed clinically or by laboratory tests; examples of possible adverse reactions/events are: anemia, thrombocytopenia (assessed by complete blood count), headache, fatigue, abdominal pain, skin rash, itching (assessed clinically by symptoms and signs)[throughout the study, by weekly clinical evaluation, complete blood count, liver and function tests.]