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临床试验/CTRI/2020/10/028651
CTRI/2020/10/028651尚未招募不适用

Sofosbuvir and Ribavirin in Subacute Sclerosing Panencephalitis

Dr Sanjay Sharma1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年10月30日最近更新:

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:

  1. Toevaluate the clinical efficacy of combo treatment of Sofosbuvir and Ribavirinon SSPE patients.

  2. 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)

研究者

申办方类型
Other [self]

研究点 (1)

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