A Control Study to Evaluate The Efficacy And Safety of Ozone-therapy in Chronic Hepatitis B

N

Nanfang Hospital, Southern Medical University

Status and phase

Completed
Phase 4

Conditions

Chronic Hepatitis B

Treatments

Device: medical ozone therapy with humares
Drug: conventional interferon-α

Study type

Interventional

Funder types

Other

Identifiers

NCT01887275
gyb61641947

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety of medical ozone in treatment of chronic hepatitis B patients.

Full description

Total of 439 patients with chronic hepatitis B were divided according to patients' intention into two arms. 173 patients in arm I were treated with medical ozone therapy with humares which was made in Germany for at least 12 weeks.266 patients in arm II were treated with conventional interferon-α for at least 24 weeks.Patients in both groups were followed-up for 24 weeks.Virology response, biochemistry response and hepatitis B viral serological response will be studied at 12 weeks after the treatment, at the end of treatment and after 24 weeks of follow-up.

Enrollment

439 patients

Sex

All

Ages

12 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female;
  • HBsAg positive for over 6 months;
  • ALT over 2×ULN, TBIL less than 80 µmol/L.

Exclusion criteria

  • Patient has a history of hemorrhagic or hemolysis disease;
  • Patient has any history of clinical signs/symptoms of hepatic decompensation or serious metabolic hepatic disease;
  • Patient is co-infected with HIV or HCV;
  • Patient is treated with anti-virus drug like interferon or nucleoside analogue in recent 6 months;
  • Patient is treated with immunosuppressive agent for long time, including patient has a history of organ transplantation;
  • Pregnancy;
  • Current alcohol or drug abuse;
  • Difficulty to draw blood through veins;
  • Patient has a history of carcinoma, or finding suggestive of possible hepatocellular carcinoma (HCC), or AFP over than 100ng/ml;
  • Patient has a history of any severe physical disease such as cardio-vascular, kidney events, hyperthyroidism or serious electrolyte disturbance;
  • Patient is enrolled in any other clinical trials.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

439 participants in 2 patient groups

medical ozone therapy with humares
Experimental group
Treatment:
Device: medical ozone therapy with humares
conventional interferon-α
Active Comparator group
Treatment:
Drug: conventional interferon-α

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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