CLINICAL TRIALS PROFILE FOR HYDROXYCHLOROQUINE SULFATE
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All Clinical Trials for Hydroxychloroquine Sulfate
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00946790 ↗ | To Demonstrate the Relative Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets | Completed | Sandoz | Phase 1 | 1993-07-01 | To demonstrate the relative bioavailability of hydroxychloroquine sulfate, 200 mg tablets. |
| NCT01551069 ↗ | Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion | Completed | Sanofi | Phase 3 | 2012-03-01 | Primary Objective: - To investigate the efficacy on skin manifestation of 16 weeks treatment of once daily regimen of hydroxychloroquine sulphate (HCQ) in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) with active skin manifestation (CLASI [Cutaneous Lupus Erythematosus Disease Area and Severity Index] activity score is ≥4) concomitant treatment with or without corticosteroid. Secondary Objectives: - To evaluate the efficacy on skin manifestation and the safety of 16 weeks treatment of once daily regiment of HCQ versus placebo as the reference group in patients with CLE and SLE with active skin manifestation (CLASI activity score is ≥4) concomitant treatment with or without corticosteroid. - To investigate the safety of 16 weeks treatment of once daily regiment of HCQ in patients with CLE and SLE with active skin manifestation concomitant treatment with or without corticosteroid. - To investigate the safety and efficacy of 52 weeks long-term treatment of once daily regimen of HCQ in patients with CLE and SLE - To investigate the influence of the dose reduction of corticosteroid on CLE and SLE patients treated with HCQ concomitant with corticosteroid - To investigate efficacy of once daily regimen of HCQ on systemic symptoms, musculoskeletal symptoms and immunological parameters in SLE patients. |
| NCT02351752 ↗ | Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy: a Self- Controlled Study | Completed | LLiu | Phase 4 | 2015-01-01 | IgA nephropathy is the most common type of primary glomerulonephritis and might caused by deposition of immune complex containing IgA in mesangium and causing local immune activation. Hydroxychloroquine reduces the activation of dendritic cells and the inflammatory process and showed the potential effect of treatment of patients with IgA nephropathy. The investigators study will recruite IgA nephropathy patients with proteinuria range from 0.75 to 3.5g/d even after three-month treatment by sufficient ACEi/ARB. The patients were treated with Hydroxychloroquine 300-400mg/d according to eGFR. The proteinuria will recorded every two months and total four months. Then, the drug will be stopped for two months for observation of change of proteinuria. |
| NCT02615938 ↗ | Hydroxychloroquin (HCQ) in Pediatric Interstitial Lung Disease (ILD) | Suspended | Matthias Griese | Phase 2 | 2015-04-01 | This is an exploratory Phase 2a, randomized, double-blind, placebo-controlled, parallel-group, multinational study investigating the initiation or withdrawal of hydroxychloroquine in subjects with chILD. |
| NCT02765594 ↗ | Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy | Unknown status | Peking Union Medical College Hospital | Phase 4 | 2016-06-01 | Immunoglobulin A nephropathy (IgAN) is the most common primary glomerulonephritis in the world.There is to date no curative therapy for patients with IgAN.It is considered that dendritic cells, Toll-like receptor (TLR) 9 and cytokines interleukin-6 (IL-6), and interferon-alpha (IFN-a) and tumor necrosis factor-alpha (TNF-α), play an important role in the aberrant mucosal response. Hydroxychloroquine is an antimalarial agent and had a notable impact on immune activation by the reduction of circulating activated immune cells that including decreased TLR-expressing cells, reduced IFN-secreting plasmacytoid dendritic cells, reduced production of inflammatory cytokines including interferon alpha, IL-6 and TNF alpha. Recent studies showed hydroxychloroquine had a benefit for renal remission and could retard the onset of renal damage in patients with lupus nephritis. hydroxychloroquine may have the potential effect in IgA nephropathy, alleviated the proteinuria and had the renal protect effect. This will be a single center, prospective, randomized, controlled study to assess the utility of hydroxychloroquine in IgAN patients. |
| NCT02942381 ↗ | A Study of Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy | Completed | Peking University First Hospital | Phase 2 | 2016-09-13 | The investigators study will recruit IgA nephropathy patients with proteinuria range from 0.75 to 3.5g/d even after three-month treatment by sufficient ACEi/ARB. The patients were treated with Hydroxychloroquine 200-400mg/d according to eGFR. The proteinuria will recorded every two months and total four months. Then, the drug will be stopped for two months for observation of change of proteinuria. |
| NCT03377179 ↗ | A Study of ABC294640 (Yeliva ®) Alone and in Combination With Hydroxychloroquine Sulfate in Treatment of Patients With Advanced Cholangiocarcinoma | Recruiting | RedHill Biopharma Limited | Phase 2 | 2018-03-07 | ABC-108 is a single-arm Phase IIA clinical study of ABC294640 (Yeliva ®, opaganib) alone and in combination with hydroxychloroquine sulfate (HCQ) in the treatment of cholangiocarcinoma (CCA). In Part 1 of this clinical study, all participants will be receiving ABC294640 and in Part 2 all participants will be receiving ABC294640 and HCQ to explore the drugs activity signal in CCA. The study drug, ABC294640 is an orally available inhibitor of the enzyme sphingosine kinase-2 (SK2). SK2 is an innovative target for anti-cancer therapy because of its critical role in sphingolipid metabolism, which is known to regulate tumor cell death and proliferation. ABC294640 also inhibits proliferation and induces apoptosis of cholangiocarcinoma cell lines. Furthermore, in a recent Phase I trial, ABC294640 demonstrated clinical activity in CCA patients. HCQ, is an orally available, FDA approved therapy for the treatment of malaria as well as discoid and systemic lupus erythematosus and rheumatoid arthritis. It is also known as an inhibitor of autophagy, a pro-survival mechanism utilized by many cancers. Evidence indicates that inhibition of autophagy can increase the therapeutic activity of ABC294640 in CCA. In Part 1 of this study, ABC294640 will be continuously administrated orally, twice a day, in 28 day cycles. In Part 2, ABC294640 and HCQ will be continuously administrated orally (the safe and tolerable will be determined in the study) in 28 day cycles. Administration of drug/s in both parts of the study will continue until disease progression, unacceptable toxicity or voluntary withdrawal initiated by the participants or physician. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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