NCT07684833尚未招募3 期
Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate Efficacy and Safety of CLR-07-23 (Heparan Sulfate 120 mg Prolonged-release Tablets) in the Treatment of Primary Chronic Venous Disease
Barbara Maglione0 个研究点目标入组 174 人开始时间: 2026年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 174
- 主要终点
- Change from Baseline in the Revised Venous Clinical Severity Score (rVCSS) at Visit 5
研究概览
简要总结
This multicenter, randomized, double-blind study is a phase III evaluates the safety and effectiveness of CLR prolonged-release tablets in patients with chronic venous insufficiency, has been shown to be effective in reducing the symptoms of itching, edema, spontaneous pain, and night cramps chronic venous disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with an age ≥ 18 and ≤ 80 years
- •Diagnosed primary venous disease of the lower limbs in stage C2 - C5 according to the CEAP classification, involvement of the venous system of the lower limbs is verified by duplex ultrasonography
- •Presence of objective signs and subjective symptoms of the disease (classified according to rVCSS score ≥ 4)
- •Participants not using or planning to use compression therapy by their own decision
- •Provision of written informed consent as approved by the Ethics Committee (EC).
排除标准
- •Use of a venoactive drug in the last month
- •Regular use of compression therapy or use of mechanical devices for reduction of edema in the last month
- •Heart Failure (NYHA class III and IV), congestive heart failure with peripheral edema
- •eGFR < 30 mL/min/1.73 m² at screening or chronic kidney disease documented in the medical history
- •ALT or AST more than 3 times the upper limit of normal range at screening or advanced liver disease documented in the medical history
- •Deep venous thrombosis lower limb thrombosis and / or documented residual venous obstruction or deep venous reflux due to post-thrombotic alterations in the deep venous system
- •Superficial venous thrombosis of the lower limbs in the previous 6 months
- •Congenital venous/lymphatic malformation
- •Neuropathy of any aetiology
- •Diabetic foot syndrome
- •Refractory (uncontrollable) hypertension (inability to therapeutically achieve a systolic blood pressure ≤ 160 mmHg or a diastolic blood pressure ≤ 100 mmHg)
- •Symptomatic ischemic disease of lower limbs
- •Lymphoedema: primary, posttraumatic, postoperative, post-radiation, malignant
- •Manual/instrumental lymphatic drainage in the last 3 months
- •Invasive procedure on the lower limbs in the last 6 months
- •Trauma of the lower extremity that has not fully healed
- •Use of oral/parenteral anticoagulants
- •Use of dual antiplatelet therapy
- •Use of loop diuretics
- •Use of oestrogens or progesterone and its derivates
- •. Use of oral/parental corticosteroids in the last 6 weeks
- •Chronic pain treatment ≥ 14 days
- •Use of psychopharmaceuticals affecting fluid retention (antipsychotics, combined antidepressants)
- •Severe obesity (BMI > 40 kg/m2)
- •Participants with active malignant disease or malignant disease in remission for less than 5 years
- •Myeloproliferative or immune disorders
- •Contraindications to the IMP/Placebo administration
- •Hypersensitivity to the IMP/Placebo excipients. General Conditions
- •Pregnant or breastfeeding women
- •Women of child-bearing potential not using at least one effective contraceptive method for the entire trial
- •Participation in other investigational drug or device clinical trials within 30 days prior to study screening
- •. Participants legally or mentally incapacitated unable to give informed consent for the participation in this trial
- •Participants unable or unwilling to comply with appointments or all protocol requirements.
结局指标
主要结局
Change from Baseline in the Revised Venous Clinical Severity Score (rVCSS) at Visit 5
时间窗: one year
Revised Venous Clinical Severity Score (rVCSS) at Visit 5 (V5) compared to Visit 1 (V1) in the two groups. The rVCSS is a clinical scale used to assess the severity of chronic venous disease. The total score ranges from a minimum of 0 (indicating no venous disease) to a maximum of 30 (indicating severe venous disease). Higher scores mean a worse clinical outcome.
次要结局
- Participant Self-Assessment of Pain Severity via Visual Analog Scale (VAS) at Visit 2 and Visit 5 Compared to Visit 1(one year)
研究者
Barbara Maglione
R&D Head Farmaceutici Damor Spa
Farmaceutici Damor Spa
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