Hepatitis B
Conditions
Interventions
Immulate Herbal Supplement
Liv. 52
Sponsors
Kantanka Herbal Pharmaceuticals and Research Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult males or females aged = 18 to = 65 years at the time screening. Capable of providing informed consent demonstrating an understanding of the study’s purpose and procedures, and expressing willingness to participate. Have documented evidence of chronic hepatitis B infection, being either immune-active or a case of immune-reactivation (i.e., HBsAg positive = 6 months with detectable HBsAg levels at screening, HBeAg reactive/non-reactive and HBV DNA viral load = 2000 IU/mL).
Exclusion criteria
Exclusion criteria: Presence of any serious acute or chronic, uncontrolled medical or mental illness that according to the judgement of the investigator, could affect a participant’s safety, ability to evaluate data, or compliance with study standards. Presence of hepatitis A, C, D, E viruses or HIV infection. Comorbidities such as renal insufficiency, autoimmune diseases and other end-organ dysfunction and malignant tumors. Volunteers using immunosuppressive therapy or radiotherapy/chemotherapy for other morbidities. Patients with liver fibrosis, cirrhosis, liver cancers and extrahepatic manifestations related to HBV (glomerulonephritis, vasculitis, nodular polyarteritis, peripheral neuropathy, etc.). Evidence of liver cirrhosis or decompensated liver disease such as Child-Pugh Class B or C, ascites, esophageal or gastric varices, hepatic encephalopathy or portal hypertension. Pregnant or having plans for a pregnancy within 1 year and lactating patients. Inability to conform to the study arrangement or complete the informed consent. Participants volunteering in other clinical studies, those not currently participating but have been dosed in another clinical study 4 weeks before screening, or those who received an investigational agent for chronic HBV infection within 6 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is a functional cure defined as the loss of HBsAg, non-reactive HBeAg combined with HBV DNA levels of = 20000 IU/mL in the peripheral blood that is sustained for a minimum of 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes to liver indices such as alanine transaminase (ALT), aspartate transaminase (AST) and gamma-glutamyl transferase (GGT) at weeks 4, 12, 20 and 36 between the two treatment arms Changes to HBsAg at weeks 12, 20 and 36 between the two treatment arms Changes to HBeAg at weeks 12, 20 and 36 between the two treatment arms Changes to HBV DNA count at weeks 12, 20 and 36 between the two treatment arms Changes to APRI (AST to Platelet Ratio Index) score at weeks 4, 12, 20 and 36 between the two arms Adverse drug reactions associated with the use of the product. | — |
Countries
Ghana
Contacts
Public ContactSardis Asamoah
MPhil Student
Outcome results
None listed