{
  "topic": {
    "stem": "ODEVIXIBAT_PFIC_REVIEW",
    "name": "Odevixibat in PFIC (PEDFIC-1/2)",
    "ncts": [
      "NCT03566238",
      "NCT03659916"
    ],
    "drug_patterns": [
      "odevixibat"
    ],
    "condition_patterns": [
      "cholestasis",
      "pfic"
    ]
  },
  "trials": [
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03566238",
        "aact_title": "This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2",
        "aact_acronym": "PEDFIC 1",
        "start_date": "2018-05-16",
        "primary_completion_date": "2020-07-27",
        "aact_intvs": [
          "A4250 (odevixibat)",
          "Placebo"
        ],
        "aact_conditions": [
          "pfic1",
          "pfic2"
        ],
        "pmid": "36066745",
        "pubmed_year": 2022,
        "pubmed_doi": "10.1007/s12325-022-02262-7",
        "aact_per_arm_counts": {
          "BG000": 20,
          "BG001": 23,
          "BG002": 19
        },
        "aact_primary_outcome_measure": "Percentage of Participants With at Least a 70% Reduction in Fasting Serum Bile Acid (s-BA) Concentration From Baseline to the End of Treatment or Reaching a Level <=70 Micromoles Per Liter (Mcmol/L) A",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "0.0"
          ],
          [
            "OG001",
            "0.0"
          ],
          [
            "OG002",
            "0.0"
          ],
          [
            "OG000",
            "4.0"
          ],
          [
            "OG001",
            "17.0"
          ],
          [
            "OG002",
            "9.0"
          ],
          [
            "OG000",
            "3.0"
          ],
          [
            "OG001",
            "13.0"
          ],
          [
            "OG002",
            "10.0"
          ],
          [
            "OG000",
            "5.0"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03659916",
        "aact_title": "Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC",
        "aact_acronym": "",
        "start_date": "2018-09-28",
        "primary_completion_date": "2024-02-15",
        "aact_intvs": [
          "A4250 (odevixibat)"
        ],
        "aact_conditions": [
          "progressive familial intrahepatic cholestasis"
        ],
        "pmid": "37456676",
        "pubmed_year": 2023,
        "pubmed_doi": "10.1016/j.jhepr.2023.100782",
        "aact_per_arm_counts": {
          "BG000": 19,
          "BG001": 37,
          "BG002": 60
        },
        "aact_primary_outcome_measure": "Change From Baseline in Serum Bile Acids",
        "aact_outcome_count_rows": [
          [
            "OG001",
            "2.8"
          ],
          [
            "OG002",
            "52.8"
          ],
          [
            "OG002",
            "58.0"
          ],
          [
            "OG000",
            "50.0"
          ],
          [
            "OG000",
            "50.0"
          ],
          [
            "OG000",
            "41.2"
          ],
          [
            "OG002",
            "56.4"
          ],
          [
            "OG000",
            "57.1"
          ],
          [
            "OG002",
            "54.9"
          ],
          [
            "OG002",
            "60.0"
          ]
        ]
      }
    }
  ],
  "gate_summary": {
    "A_aact_exists": 2,
    "B_drug_in_intvs": 2,
    "C_condition_in_aact": 2,
    "D_pmid_topic_match": 2,
    "E_two_arms": 2,
    "F_primary_outcome_known": 2
  },
  "n_total": 2,
  "n_pass_all": 2,
  "pass_rate": 1.0,
  "verdict": "VIABLE"
}