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

NCT01887275 | Completed Phase 4 DMC

• 1 other identifier: gyb61641947
• Study Type: interventional
• Target: 439
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Hepatitis B

Keywords

Chronic hepatitis B; Medical Ozone; Interferon-α; Efficacy

Outcome Measures

Primary Outcomes (1)

• HBV DNA

  To demonstrate the percentage of patients achieving HBV DNA\<1000copies/mL

  up to 77 weeks

Secondary Outcomes (1)

• HBeAg

  up to 77 weeks

Study Arms (2)

medical ozone therapy with humares

EXPERIMENTAL

Device: medical ozone therapy with humares

conventional interferon-α

ACTIVE COMPARATOR

Drug: conventional interferon-α

Interventions

medical ozone therapy with humares DEVICE

Medical ozone therapy with instrument made in Germany Patients in this group will receive autohemotherapy treatment. First month: ozone concentration: 20µg \~40µg /ml;The second month: 30µg/ml × 100ml oxygen- ozone gas × 100 ml blood;The third month: 20µg/ml × 100ml oxygen- ozone gas× 100 ml blood.

Also known as: ozone instrument made in Germany: Humares

medical ozone therapy with humares

conventional interferon-α DRUG

Patients in the conventional interferon-α treatment group received subcutaneouslly injection of 5 million units of conventional interferon-α in three times per week for at least 24 weeks.

conventional interferon-α

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• yabing guo, professor

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2013
• First Posted: June 26, 2013
• Study Start: March 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: June 26, 2013

Record last verified: 2012-10

Locations

CN (1)