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Table 3 Exclusion criteria for patients to participate at the study

From: Prospective evaluation of hydroxychloroquine in pediatric interstitial lung diseases: Study protocol for an investigator-initiated, randomized controlled, parallel-group clinical trial

1.chILD primarily related to developmental disorders; chILD primarily related to growth abnormalities reflecting deficient alveolarizationa; chILD related to chronic aspiration; chILD related to immunodeficiency; chILD related to abnormalities in lung-vessel structure; chILD related to organ transplantation/organ rejection/GvHD; chILD related to recurrent infection
2.Acute severe infectious exacerbations
3.Known hypersensitivity to HCQ, or other ingredients of the capsules (lactose monohydrate, povidone, maize starch, magnesium stearate, hypromellose, macrogol or titanium dioxide (E 171), silicon dioxide or mannitol), to sucrose octaacetate or sodium saccharin
4.Proven retinopathy or maculopathy
5.Glucose-6-phosphate-dehydrogenase deficiency resulting in favism or hemolytic anemia, myasthenia gravis, hematopoietic disorders
 Pregnancy and lactation (women with childbearing potential have to practice a medically accepted contraception during the trial and til 3 months after the end of the treatment with HCQ, and a negative pregnancy test (serum or urine) should be existent on visit 1 if they are girls of childbearing age and only if sexual relations are known or probable. It is at the discretion of and is the responsibility of the attending physician to decide whether a pregnancy test is necessary or not. Reliable contraceptives are systematic contraceptives (oral, implant, injection). Women who are sterile through surgery can participate in the trial. At the discretion of the investigator, sexual abstinence is also accepted as a contraceptive method. Girls after the menarche must receive counseling about birth control methods in the presence of at least one parent, which has to be documented in the patient’s notes
6.Participation in other clinical trials during the present clinical trial or not beyond the time of 4 half-lives of the medication used, at least 1 week
7.Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption
8.Renal insufficiency at screening, defined as glomerular filtration rate (GFR)
< 40 mL/min/1.73 m2 in patients aged 3 to 8 weeks
<  60 mL/min/1.73 m2 in patients ≥ 8 weeks of age
9.Liver disease, gastrointestinal disorder, hematological disorder, epilepsy or other neurological disorder, psoriasis, porphyria at the discretion of the treating physician
10.Simultaneous prescription of other potentially nephrotoxic or hepatotoxic medication at the discretion of the treating physician
  1. List of abbreviations: chILD  children’s interstitial lung disease, GvHD graft versus host disease, mL milliliter, min minutes, GFR glomerular filtration rate, HCQ hydroxychloroquine
  2. aIf not diagnosed with a specific genetic cause (listed in Table 3)