Sofosbuvir and Ribavirin in Subacute Sclerosing Panencephalitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Mortality at 18 month
研究概览
简要总结
SubacuteSclerosing Panencephalitis (SSPE) is a slow virus infection caused by themutant measles virus. Most patients with SSPE have a history of primary measlesdisease in early childhood below two years. SSPE is a rare and now prevalentonly in the Indian subcontinent. An annual incidence of 21 per millionpopulations in India reported in the literature. The disease has orphan statuswith no substantial advancement in diagnostic or therapeutic modalities. Noadequate therapy is currently available for the treatment of SSPE. As a result,the patients suffering from SSPE survive only for 1- 3 years after diagnosis,with a mean survival of about 18 months.
Observationsof some non- randomized trials suggest that specific antiviral drugs andimmune-modulator agents can prolong life. A combination of intra-ventricularinterferon alfa plus oral Isoprinosine / Ribavirin is the best effectivetreatment available. It is observed that development of C treatment modalitiesfor SSPE and Hepatitis-C. Is similar before development of newer antiviralagents for cure of Hepatitis-C.
Comparisonbetween SSPE and Hepatitis- C is given in table below
| SSPE |
HEPATITIS- C
|Type of virus
RNA
RNA
|Latent period before disease manifestation
Prolonged and variable
Prolonged and variable
|Treatment
|Alfa interferon
Yes
Yes
|Ribavirin
Yes
Yes
|Combined treatment Alfa interferon + Ribavirin
Yes
Yes
|Newer drugs
No
Yes
|Outcome
Mostly fatal
Curable due to newer antiviral
Ribavirin isan antiviral medication used to treat respiratory syncytial virus infection,hepatitis C and some viral hemorrhagic fevers. Sofosbuvir recommended treating Hepatitis C in combination with Ribavirin,interferon- alfa, and newer antiviral agent. Common side effects of Sofosbuvirinclude feeling tired, headache, nausea, and trouble sleeping. Side effects aremore common in interferon-containing regimens.
Aim:
-
Toevaluate the clinical efficacy of combo treatment of Sofosbuvir and Ribavirinon SSPE patients.
-
To notethe impact of combo therapy on the survival of SSPE patients.
Objectives:
To assessthe outcome of SSPE after 3- 6 months of combined treatment with Sofosbuvir andRibavirin.
Methodology:
Thestudy is a non- placebo purely observational and repositioning trial withRibavirin with Sofosbuvir in the treatment of SSPE. All patients will betreated with standard care with anti-epileptic drugs, amantadine, and oraldoses of Ribavirin. Also, they will receive Sofosbuvir according to body weight(150- 200 mg/day) for three months. One minute home video recording of everypatient will be analyzed for frequency of myoclonic jerks and overallimprovement every three months after induction to treatment, and survival willbe recorded at 18 months of all enrolled patients in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 5.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- All
入选标准
- •Children and adult with Subacute Sclerosing Pan Encephalitis.
排除标准
- •Parents not willing to participate in study.
结局指标
主要结局
Mortality at 18 month
时间窗: Mortality at 18 month
次要结局
- Improvement or cessation in clinical deterioration(18 month)
