Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The REP 301 treatment protocol involved the treatment of patients with chronic hepatitis B / hepatitis D co-infection with two agents: REP 2139-Ca and pegylated interferon (peg-IFN). In this protocol, similar reduction/clearance of serum HBsAg and improved response to immunotherapy were observed in addition to clearance of serum HDV RNA. The REP 301 protocol was designed to include a 24 week follow-up period after treatment, however given the strong antiviral response against HBV and HDV infection in these patients, it is now important to extend the follow-up period in these patients to monitor over a longer period after treatment the safety and efficacy combined REP 2139-Ca / peg-IFN treatment in patients in the REP 301 protocol.
The REP 301-LTF is a long-term follow-up, non-blinded study of patients from the REP 301 protocol. In this study, all eligible patients from the REP 301 protocol will have their followup evaluation extended for an additional 3 years, consisting of 6 visits scheduled every 6 months following the last follow-up visit scheduled in the REP 301 protocol. During each visit a physical examination and documentation of any symptoms, experiences will be conducted as well as blood tests for safety and virology as described below. This study will examine the long term safety effects in patients who have completed of treatment exposure in the REP 301 trial (REP 2139-Ca therapy for 30 weeks and PEG-IFN taken for 48 weeks with a 15 week overlap in combination) and the duration of suppression of serum HBV and HDV viremia observed in the REP 301 protocol. This requires that subjects have completed antiviral treatment in the REP 301 protocol and are not immediately transitioned to further antiviral treatment unless necessary. The total duration of this study for each subject is 3 years.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Long term safety (test abnormalities) | The proportion of patients with emergent lab test abnormalities. | 3 years |
| Long term safety (AEs) | Proportion of patients with adverse events. | 3 years |
| Long term safety (SAEs) | Proportion of patients with serious adverse events. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Long term efficacy (serum HBsAg) | Proportion of patients who maintain serum HBsAg < 1 IU/ml. | 3 years |
| Long term efficacy (serum anti-HBs) | Proportion of subjects who maintain anti-HBs titers above 10 mIU/ml. |
Not provided
Inclusion Criteria:
1. Signed written informed consent.
Exclusion Criteria:
Not provided
Not provided
Patients completing treatment exposure in the REP 301 protocol.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Victor Pantea, MD | Infectious Clinical Hospital (n.a. Toma Ciorba) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Clinical Hospital (n.a. Toma Ciorba) | Chisinau | 2004 | Moldova |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33553968 | Derived | Bazinet M, Pantea V, Cebotarescu V, Cojuhari L, Jimbei P, Anderson M, Gersch J, Holzmayer V, Elsner C, Krawczyk A, Kuhns MC, Cloherty G, Dittmer U, Vaillant A. Persistent Control of Hepatitis B Virus and Hepatitis Delta Virus Infection Following REP 2139-Ca and Pegylated Interferon Therapy in Chronic Hepatitis B Virus/Hepatitis Delta Virus Coinfection. Hepatol Commun. 2020 Nov 13;5(2):189-202. doi: 10.1002/hep4.1633. eCollection 2021 Feb. | |
| 28964701 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D019701 | Hepatitis D, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Frozen serum containing viral DNA / RNA
| 3 years |
| Long term efficacy (serum HBV DNA) | Proportion of patients who maintain serum HBV DNA < 10 IU / ml. | 3 years |
| Long term efficacy (serum HDV RNA) | Proportion of patients who maintain undetectable serum HDV RNA (target not detected). | 3 years |
| Derived |
| Bazinet M, Pantea V, Cebotarescu V, Cojuhari L, Jimbei P, Albrecht J, Schmid P, Le Gal F, Gordien E, Krawczyk A, Mijocevic H, Karimzadeh H, Roggendorf M, Vaillant A. Safety and efficacy of REP 2139 and pegylated interferon alfa-2a for treatment-naive patients with chronic hepatitis B virus and hepatitis D virus co-infection (REP 301 and REP 301-LTF): a non-randomised, open-label, phase 2 trial. Lancet Gastroenterol Hepatol. 2017 Dec;2(12):877-889. doi: 10.1016/S2468-1253(17)30288-1. Epub 2017 Sep 28. |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003699 | Hepatitis D |
| D012327 | RNA Virus Infections |