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. 2014 Feb 28;2014(2):CD005441. doi: 10.1002/14651858.CD005441.pub3

Derbala 2006.

Methods Study design: randomised clinical trial.
Participants Country: Egypt.
Total number: 73 (seven participants did not continue the treatment).
Age, years: 45.5.
Sex (male): 31% to 33%.
Comorbidity: bilharziasis.
Genotype: four.
Previous HCV treatment: naïve.
Inclusion criteria: chronic active hepatitis C as evidenced by the following.
  • Positive serological test for HCV‐Ab.

  • Detectable serum HCV‐RNA.

  • Elevated serum alanine transaminases.

  • Histopathological criteria of chronic active hepatitis.


Exclusion criteria.
  • Patient with hepatocellular carcinoma.

  • Positive serum pregnancy test and breast feeders.

  • Coinfected patients with HBV, HIV.

  • Patient with other chronic liver disease.

Interventions Group A (n = 38).
  • Drug: peginterferon alpha‐2a.

  • Dosage: 180 µg.

  • Ribavirin dose: 1200 mg daily.


Group B (n = 35).
  • Drug: INF 2a.

  • Dosage: 3 MU three times.

  • Ribavirin dose: 1200 mg daily.

Outcomes Primary outcomes: end of treatment response, sustained virological response, adverse events.
Notes Published article.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comments: Method used to perform sequence generation is not mentioned.
Allocation concealment (selection bias) Unclear risk Comments: Allocation concealment is not mentioned.
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Comments: Blinding to the outcome assessor is not mentioned.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comments: Incomplete outcome data were addressed adequately.
Selective reporting (reporting bias) Low risk Comment: All clinically relevant and reasonably expected outcomes were reported.
Other bias Low risk Comment: The trial seems to be free of other sources of bias.