NCT05193994终止3 期
Randomised Double-Blind Placebo-Controlled Phase 3 Trial of Triumeq in Amyotrophic Lateral Sclerosis
Macquarie University, Australia28 个研究点 分布在 8 个国家目标入组 419 人开始时间: 2022年2月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 419
- 试验地点
- 28
- 主要终点
- Measure overall survival at 24 months or after a minimum of 212 events
研究概览
简要总结
To determine if Triumeq improves survival in Amyotrophic Lateral Sclerosis (ALS) compared with placebo
详细描述
This Randomised Double-Blind Placebo Controlled trial seeks to investigate whether the combination medicine Triumeq (dolutegravir 50mg, abacavir 600mg, lamivudine 300mg), already sold in Australia for HIV treatment is effective in delaying progression of theAmyotrophic Lateral Sclerosis (ALS) disease and if it is safe and well tolerated in patients with ALS. This medication is very commonly prescribed for patients with HIV. The secondary aim of this study is to assess patient's health outcomes whilst taking this medication for their ALS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at the time of screening
- •Diagnosis of ALS according to the Gold Coast Criteria
- •Capable of providing informed consent and complying with trial procedures
- •TRICALS risk profile > -6.0 and < -2.0
- •Those taking Riluzole must be on a stable dose for at least 30 days prior to the baseline visit or must have stopped taking Riluzole at least 30 days prior to the baseline visit
- •Women must not become pregnant (e.g., post-menopausal, surgically sterile, using highly effective birth control methods or not having potentially reproductive sex) for the duration of the study plus five days. Highly effective methods of birth control are those with a failure rate of < 1% per year when employed consistently and correctly, e.g. Combined (oestrogen and progestogen containing) hormonal contraception or progestogen-only hormonal contraception. For more information, please refer to the HMA CTFG Guidelines: https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf?fbclid=IwAR3AY5Ha0ESDyqIBeUaYI9VTFWmx9bbt8NZ-80N-5ME6pkBb1UHvFsTwqlQ
- •Women of childbearing potential must have a negative serum pregnancy test at screening and be non-lactating. Patients will be advised regarding appropriate contraception. A menstruation history will be taken at each visit. Women of childbearing potential are defined as females who are fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy (https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf?fbclid=IwAR3AY5Ha0ESDyqIBeUaYI9VTFWmx9bbt8NZ-80N-5ME6pkBb1UHvFsTwqlQ)
- •For participants taking antacids (regularly or as required), participant is willing and able to avoid taking antacids for at least 6 hours before and 2 hours after Triumeq
- •Participant taking taurursodiol supplements (TUDCA) can participate in this trial if the supplement does not contain sodium phenylbutyrate.
- •Participants taking taurursodiol supplements (TUDCA) that also contain sodium phenylbutyrate must be willing to stop supplementation 30 days prior randomisation.
排除标准
- •People who are HLA-B*5701 positive
- •Known hypersensitivity to Dolutegravir, Abacavir or Lamivudine, or to any of the excipients
- •Safety Laboratory Criteria at screening:
- •ALT ≥ 5 times upper limit of normal (ULN)
- •AST ≥ 3 times ULN
- •Bilirubin ≥ 1.5 times ULN with clinical indicators of liver disease
- •Creatinine clearance < 30 mL / min
- •Platelet concentration of < 100 x109 per L
- •Absolute neutrophil count of < 1x109 per L
- •Haemoglobin < 100 g/L
- •Amylase ≥ 2 times ULN
- •Lactate ≥ 2 times ULN
- •Moderate to severe hepatic impairment, as defined by local clinical guidelines
- •Presence of HIV antibodies at screening
- •Presence of Hepatitis C antibodies at screening unless participants have had effective treatment for Hepatitis C
- •Presence of Hepatitis B core or surface antigen at screening
- •Participation in any other investigational drug trial or using investigational drug within 30 days prior to screening
- •Use of NIV ≥22 h per day or having a tracheostomy
- •Edaravone dose within 30 days prior to screening. Edaravone is approved by the FDA and in Japan, but remains an investigational product in Europe and Australia
- •Clinically significant history of unstable or severe cardiac, oncological, psychiatric, hepatic, or renal disease or other medically significant illness
- •Taking medication contraindicated with Triumeq: Dofetilideor Fampridine (dalfampridine)
- •Taking Tofersen within 3 months prior to screening.
研究组 & 干预措施
Dolutegravir/Abacavir/Lamivudine
Experimental
Combination of Dolutegravir, Abacavir and Lamivudine in a single product/capsule.
4 capsules to be taken orally once daily (all 4 at the same time, each capsule is Dolutegravir 12.5mg, Abacavir 150mg and Lamivudine 75mg). Maximum duration is 24months
干预措施: Dolutegravir, Abacavir and Lamivudine (Drug)
Placebo
Placebo Comparator
4 capsules to be taken orally once daily (all 4 at the same time). Maximum duration is 24months
干预措施: Placebo (Drug)
结局指标
主要结局
Measure overall survival at 24 months or after a minimum of 212 events
时间窗: 24 months
Overall survival is measured as death from any cause, in participants with ALS at 24 months, or after a minimum of 212 events.
次要结局
- Measure scoring in the ALS-Functional Rating Scale Revised (ALSFRS-R) at 3 monthly intervals.(24 months)
- Measure study medication discontinuation(24 months)
- Assign a value using the King's Staging Scale to describe degree of disease advancement over time(24 months)
- Number of participants with abnormal Slow Vital Capacity measured by hand spirometry at 3 monthly intervals(24 months)
- Measure plasma creatinine at 3 monthly intervals(24 months)
- Evaluate the incidence of treatment-emergent adverse events(24 months)
- Measure the score obtained with the Edinburgh Cognitive and Behavioural Assessment Screen (ECAS)(24 months)
- Measure the responses in the EQ-5D-5L quality of life health questionnaire.(24 months)
- Measurement of several biomarkers from blood and urine samples(24 months)
研究者
研究点 (28)
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